FDA Adverse Event
Malfunction
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2221223
·
Received August 24, 2011
Report
- Report Number
- 3002648230-2011-00139
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 25, 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. THE VISUAL INSPECTION SHOWED THAT THE SIDEPORT TUBE WAS DETACHED FROM THE HANDLE. THE SIDEPORT TUBE WAS INTACT WITH NO APPARENT ISSUES. THIS REPORT WILL BE RECORDED AND TRENDED.
Description of Event or Problem · 1
THE EXTENSION TUBING OF THE FLEXCATH STEERABLE SHEATH WAS TORN DURING A PROCEDURE PERFORMED IN (B)(6). 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 | 36905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |