FDA Adverse Event
Injury
Summary report: N
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
MDR report key: 4242015
·
Received November 10, 2014
Report
- Report Number
- 9673241-2014-00473
- Event Type
- Injury
- Date Received
- November 10, 2014
- Date of Event
- October 14, 2014
- Report Date
- October 16, 2014
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- LPB
- PMA / PMN Number
- P030031/S053
- Removal / Correction Number
- NA
- Adverse Event
- 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 DURING AN ABLATION PROCEDURE USING A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER, A PERICARDIAL EFFUSION WAS DIAGNOSED. UPON REQUEST, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD TO BE TREATED FOR PERSISTENT ATRIAL FIBRILLATION. A STEAMPOP WAS HEARD DURING THE ABLATION. A PERFORATION AT THE RIDGE OF THE LEFT ATRIUM WAS NOTICED APPROXIMATELY 4 HOURS POST PROCEDURE. A THORACOTOMY WITH SURGICAL INTERVENTION TO CLOSE THE PERFORATION WAS PERFORMED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722243 | THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1336-01-S | UNK_D-1336-01-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R |