FDA Adverse Event
Malfunction
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2153663
·
Received July 7, 2011
Report
- Report Number
- 3002648230-2011-00073
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- DRA
- PMA / PMN Number
- K081049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING. DISSECTION SHOWED A LEAKING HEMOSTATIC VALVE.
Description of Event or Problem · 1
DURING A CRYOABLATION PROCEDURE, THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER) ALLOWED AIR TO BE ASPIRATED INTO THE SHEATH THROUGH THE SIDE PORT. THE SHEATH WAS REPLACED BY ANOTHER FLEXCATH STEERABLE SHEATH OF THE SAME LOT, AND THE SAME PROBLEM WAS NOTICED. THE CRYOABLATION PROCEDURE WAS COMPLETED AND NO ADVERSE EVENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXCATH STEERABLE SHEATH | CATHETER, STEERABLE | DRA | MEDTRONIC CRYOCATH LP | 3FC12 | 38074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |