FDA Adverse Event
Malfunction
Summary report: N
THERMOCOOL SMARTTOUCH SF
MDR report key: 20782285
·
Received November 26, 2024
Report
- Report Number
- 20782285
- Event Type
- Malfunction
- Date Received
- November 26, 2024
- Date of Event
- October 1, 2024
- Report Date
- October 14, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EVENT 1 [REDACTED DATE] BIOSENSE WEBSTER, INC. D134805, 31436931L. THERE WAS CHAR ON THE TIP OF THE ABLATION CATHETER. EVENT 2 [REDACTED DATE] BIOSENSE WEBSTER, INC. D134805, 31379137L. DURING PREP OF THE ABLATION CATHETER, THERE WAS A CONNECTION ERROR. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. EVENT 3 [REDACTED DATE] BIOSENSE WEBSTER, INC. D134805, 31412419L. THERE WAS A SENSOR ERROR WITH THE ABLATION CATHETER AFTER PLACED INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR ABLATION CATHETER, ABLATION CATHETER (PER SITE REPORTER) MFG NOTIFIED BY SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2598061 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | D134805 | 31436931L, 31379137L,31412419L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |