FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F, 1304-CP-7-25-M-AB (USA)
MDR report key: 2021350
·
Received February 8, 2011
Report
- Report Number
- 2030404-2011-00034
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 3, 2011
- Report Date
- February 4, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATIONS HAVE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER IS CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. THE SALINE ENTERED THE CATHETER CONNECTOR AND CREATED A CONDUCTOR WIRE SHORT WHICH RESULTED IN THE REPORTED ERROR MESSAGE ON THE GENERATOR. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. (B)(4).
Description of Event or Problem · 1
INVESTIGATION OF A CATHETER RETURNED DUE TO A TEMPERATURE ERROR MESSAGE ON THE GENERATOR, REVEALED A HANDLE LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH 7F, 1304-CP-7-25-M-AB (USA) | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 84308 | 3212753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |