FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
MDR report key: 2145709
·
Received May 26, 2011
Report
- Report Number
- 2030404-2011-00154
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 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
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
SAME CASE AS MANUFACTURER REPORT #2030404-2011-00151. IT WAS REPORTED THE IRRIGATION PORT ON THE COOL PATH DUO CATHETER BROKE DURING AN ABLATION PROCEDURE. THE PHYSICIAN WAS USING THE CATHETER FOR APPROXIMATELY 30 MINUTES WHEN THE IRRIGATION PORT BROKE. THE SAME ISSUE ALSO HAPPENED WITH THE FIRST CATHETER USED DURING THE PROCEDURE. 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)-L1-TE4BE1AB | CARDIAC ABLATION PERCUTANEOUS CATHETER | OAD | ST. JUDE MEDICAL, IRVINE | 83565 | 3202861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COOL PATH CATHETER: MODEL 83565, LOT 3185677 |