FDA Adverse Event
Malfunction
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2183208
·
Received July 28, 2011
Report
- Report Number
- 3002648230-2011-00098
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 29, 2011
- Report Date
- June 29, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- DRA
- PMA / PMN Number
- K081049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. A FIELD ACTION WAS INITIATED IN (B)(4) 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.
Description of Event or Problem · 1
DURING A CRYOABLATION PROCEDURE, THERE WAS A LEAK FROM THE VALVE OF THE FLEXCATH STEERABLE SHEATH AND AIR BUBBLES WERE SUCKED IN THROUGH THE SIDE PORT DURING THE ASPIRATION PROCESS. 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 | 35329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |