FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
MDR report key: 2033639
·
Received February 11, 2011
Report
- Report Number
- 2030404-2011-00036
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 17, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. THERE WERE NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 83565 | 3198427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |