FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
MDR report key: 1922597
·
Received November 19, 2010
Report
- Report Number
- 2030404-2010-00235
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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. FORTY FIVE MINUTES INTO THE PROCEDURE (AF ABLATION) THE CATHETER STARTED TO LEAK ON THE PROXIMAL PORTION OF THE CATHETER HANDLE. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 83563 | K28975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |