FDA Adverse Event
Malfunction
Summary report: N
COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB
MDR report key: 1932081
·
Received November 30, 2010
Report
- Report Number
- 2030404-2010-00251
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 3, 2010
- Manufacturer
- ST JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. 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
IT WAS REPORTED THERE WAS A HANDLE LEAK. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB | NONE | OAD | ST JUDE MEDICAL, IRVINE | 83503 | K27913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |