FDA Adverse Event
Injury
Summary report: N
THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
MDR report key: 3200273
·
Received July 1, 2013
Report
- Report Number
- 9673241-2013-00217
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- May 16, 2013
- Report Date
- June 14, 2013
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- LPB
- PMA / PMN Number
- P030031/S034
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED; THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT. THE PROCEDURE WAS STOPPED AFTER THIS EFFUSION. THE PATIENT NEEDED 3 DAYS HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298410 | THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1318-03-S | 15692650L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |