FDA Adverse Event
Malfunction
Summary report: N
NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
MDR report key: 4039050
·
Received August 26, 2014
Report
- Report Number
- 9673241-2014-00323
- Event Type
- Malfunction
- Date Received
- August 26, 2014
- Date of Event
- July 30, 2014
- Report Date
- August 5, 2014
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE END OF THE PROCEDURE THE PHYSICIAN REALIZED A CHAR AT THE PROXIMAL END OF THE DISTAL ELECTRODE. DURING THE PROCEDURE THERE WERE NO COMPLICATIONS AND NO PATIENT CONSEQUENCE. THE PATIENT OUTCOME WAS GOOD. THE ACT LEVEL WAS GOOD. ACT: 360, 252, 389, 396, 362, 389. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE EVENT. HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515945 | NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1197-17-S | UNKNOWN_D-1197-17-S_JUA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |