FDA Adverse Event
Malfunction
Summary report: N
COOL PATH CATHETER 7F, 1304-CP-7-25-L
MDR report key: 2092953
·
Received April 20, 2011
Report
- Report Number
- 2030404-2011-00106
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ST. JUDE MEDICAL, 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
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 CATHETER FOR AN ABLATION PROCEDURE, AN OCCLUSION ALARM WAS NOTED ON THE IRRIGATION PUMP AND IT WAS NOTED THE HANDLE OF THE CATHETER WAS LEAKING. THERE WERE NO CONSEQUENCES TO THE PT. ADD'L INFO WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH CATHETER 7F, 1304-CP-7-25-L | CARDIAC ABLATION CATHETER | OAD | ST. JUDE MEDICAL, IRVINE | 83353 | 32289502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |