FDA Adverse Event
Injury
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2802692
·
Received October 24, 2012
Report
- Report Number
- 3002648230-2012-00093
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 26, 2012
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- DRA
- PMA / PMN Number
- K081049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.
Description of Event or Problem · 1
POST CRYOABLATION PROCEDURE, THE PATIENT HAD A CARDIAC TAMPONADE. PATIENT HAD A DECREASE IN BLOOD PRESSURE AND CHEST PAIN DUE TO THE CARDIAC TAMPONADE. SURGICAL INTERVENTION (PERIOCARDIOCENTESIS) WAS REQUIRED TO TREAT THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXCATH STEERABLE SHEATH | CATHETER, STEERABLE | DRA | MEDTRONIC CRYOCATH LP | 3FC12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | CATHETERS: CRYOABLATION 2AF283, MAPPING (B)(4) |