FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB
MDR report key: 2153469
·
Received June 21, 2011
Report
- Report Number
- 2030404-2011-00187
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 2011
- 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
WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE IRRIGATION PORT DETACHED FROM THE HANDLE OF THE CATHETER. THE DETACHMENT OCCURRED DURING THE FIRST TWENTY MINUTES OF THE CASE. THERE WERE NO 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)2-M-TE4BE1AB | CARDIAC ABLATION PERCUTANEOUS CATHETER | OAD | ST. JUDE MEDICAL, IRVINE | 83562 | 3279901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |