Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1251 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Temporary Catheter LIGHT-BOOK · MAUDE
#1000 of 1000 · 364 reports · 2018–2026
- BOOK 364 reports
- RANK #1000 of 1000
- DEATH 5 death-typed
- INJ 72 injury-typed
- MALF 287 malfunction
- SPAN 2018–2026
- PEAK 2020: 73
- PHOTO Mediastinoscope
Nearest event-volume peer: Mediastinoscope, Surgical (0 report gap)
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures sits #1000 of 1000 among tracked device types with 364 MAUDE reports spanning 2018–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Temporary Catheter carries 78.8% MALFUNCTION-coded reports, 14.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
- INJ 19.8% corpus 30.3% · below corpus mean (-10.5 pp)
- MALF 78.8% corpus 64.8% · above corpus mean (+14.0 pp)
Lead product-problem code Difficult to Remove is 24% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 100% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Temporary Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Light
Light, Surgical, Accessories
369 reports
- Material
Material, Impression
369 reports
- Balloon Aorti…
Balloon Aortic Valvuloplasty
367 reports
- Microscope
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
366 reports
- Temporary Cat… (this)
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
364 reports
- Mediastinosco…
Mediastinoscope, Surgical
364 reports
What this shows Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures carries 364 MAUDE reports, ranked #1000 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 50 in 2025, up from an average of 35 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC MINIMED →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Temporary Catheter: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (364 here).
Similar death-typed counts
Nearest other device types by death-typed report count (5 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Temporary Catheter are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Temporary Catheter; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.