FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F, 1304-CP-7-25-L-AB (USA)
MDR report key: 2081163
·
Received April 14, 2011
Report
- Report Number
- 2030404-2011-00099
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- February 16, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING DEVICE RETURN. IF THE DEVICE IS RETURNED FOR EVALUATION, A FOLLOWUP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED WHILE USING THE CATHETER FOR AN ABLATION PROCEDURE, THE CATHETER STARTED LEAKING FROM THE HANDLE. THE PHYSICIAN REPLACED THE CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH 7F, 1304-CP-7-25-L-AB (USA) | THERAPY COOL PATH ABLATION | OAD | ST. JUDE MEDICAL, IRVINE | 84309 | 3285255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |