FDA Adverse Event
Malfunction
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2123272
·
Received June 14, 2011
Report
- Report Number
- 3002648230-2011-00047
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- DRA
- PMA / PMN Number
- K081049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 PERFORMED IN (B)(6), AIR WAS NOTICED IN THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER). THE SHEATH WAS REPLACED WITH ANOTHER FLEXCATH STEERABLE SHEATH, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXCATH STEERABLE SHEATH | CATHETER, STEERABLE | DRA | MEDTRONIC CRYOCATH LP | 3FC12 | 35328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |