FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F, 1304-CP-7-25-M
MDR report key: 2103386
·
Received May 17, 2011
Report
- Report Number
- 2030404-2011-00141
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 21, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATELY (B)(6) YEARS OLD. WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED WHILE USING THE COOL PATH CATHETER DURING AN ABLATION PROCEDURE THE IRRIGATION PORT FELL OFF THE HANDLE. THE CATHETER WAS BEING USED WITH A STOCKERT GENERATOR AND A PUMP RUNNING AT 30ML PER MINUTE WHEN HIGH TEMPERATURES WERE NOTED ON THE GENERATOR. THE CATHETER WAS REMOVED AND REPLACED WITH A COOLFLEX CATHETER AND THE PROCEDURE CONTINUED WITHOUT CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH 7F, 1304-CP-7-25-M | CARDIAC ABLATION PERCUTANEOUS CATHETER | OAD | ST. JUDE MEDICAL, IRVINE | 83352 | 3279895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COOLFLEX CATHETER: MODEL 88015 |