FDA Adverse Event
Injury
Summary report: N
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
MDR report key: 2191462
·
Received August 4, 2011
Report
- Report Number
- 3002648230-2011-00111
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- OAE
- PMA / PMN Number
- P100010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE SINCE NO MALFUNCTION OCCURRED DURING THE PROCEDURE.
Description of Event or Problem · 1
A CRYOABLATION PROCEDURE WAS PERFORMED AND THREE PULMONARY VEIN ISOLATIONS WERE COMPLETED. SIXTY SECONDS INTO THE FIRST ABLATION ON THE RSPV, WHILE PACING THE PHRENIC NERVE AND FEELING THE PATIENT'S CHEST, THE PHYSICIAN NOTICE A LOSS OF PHRENIC NERVE CAPTURE. THE ABLATION WAS IMMEDIATELY STOPPED AND NO FURTHER ABLATIONS WERE PERFORMED. AFTER 45 MINUTES, THERE WAS SOME RECOVERY OF THE PHRENIC NERVE, BUT IT WAS WEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCTIC FRONT CARDIAC CRYOABLATION CATHETER | OAE | MEDTRONIC CRYOCATH LP | 2AF232 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Disability |