FDA Adverse Event
Malfunction
Summary report: N
COOL PATH CATHETER 7F, 1304-CP-7-25-L
MDR report key: 1860133
·
Received September 21, 2010
Report
- Report Number
- 2030404-2010-00144
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 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 THERE WAS NO ISSUE RELATED TO COMPLAINT DURING MFG PROCESS. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. DATE REPORT SUBMITTED TO FDA BY MFR: 09/21/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED, THE CATHETER HANDLE LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH CATHETER 7F, 1304-CP-7-25-L | NONE | OAD | ST JUDE MEDICAL, IRVINE | 83353 | K28309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |