FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F, 1304-CP-7-25-L1-AB
MDR report key: 3102326
·
Received April 30, 2013
Report
- Report Number
- 2030404-2013-00034
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC. (AF-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
THE DEVICE IS IN THE PROCESS OF BEING ANALYZED. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING A KENT FASCICLE ABLATION PROCEDURE USING A THERAPY COOL PATH ABLATION CATHETER, THE IRRIGATION PORT OF THE CATHETER WAS LEAKING. APPROXIMATELY 30 MINUTES INTO THE PROCEDURE AFTER SEVERAL SUCCESSFUL LESIONS WERE PLACED, THE PHYSICIAN NOTED THE POWER ON THE GENERATOR WOULD NOT GO ABOVE 2 WATTS. VISUAL ASSESSMENT OF THE CATHETER REVEALED THE IRRIGATION PORT WAS BROKEN AND LEAKING. THERE WERE NO CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188002 | COOL PATH 7F, 1304-CP-7-25-L1-AB | CARDIAC ABLATION PERCUTANEOUS CATHETER | OAD | ST. JUDE MEDICAL, INC. (AF-IRVINE) | 83505 | 3556225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FAST CATH INTRODUCER (406108/LOT UNKNOWN) |