FDA Adverse Event
Malfunction
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2130445
·
Received June 16, 2011
Report
- Report Number
- 3002648230-2011-00050
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 10, 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
- NY, 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
A CRYOABLATION PROCEDURE WAS PERFORMED. THE ARCTIC FRONT CATHETER WAS INSERTED INTO THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER). DURING ASPIRATION OF THE FLEXCATH SHEATH, AIR WAS ENTERING THE SHEATH THROUGH THE VALVE. THE SHEATH WAS REPLACED BY ANOTHER FLEXCATH STEERABLE SHEATH AND THE PROCEDURE WAS COMPLETED. 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 | 23512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |