FDA Adverse Event
Malfunction
Summary report: N
COOL FLEX CATH, 1304-CF-7-0.5(5)5-L-TE4BE1EB
MDR report key: 1963652
·
Received December 21, 2010
Report
- Report Number
- 2030404-2010-00272
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 25, 2010
- Report Date
- November 25, 2010
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED "POP" REMAINS UNKNOWN. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/21/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4)2010.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A "POP" WHEN USING A COOLFLEX ABLATION CATHETER. THE POP OCCURRED WHEN THE PHYSICIAN WAS USING 30 WATTS OF POWER WITH 15ML/MIN IRRIGATION WHILE PERFORMING AN ATRIAL FLUTTER ABLATION PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL FLEX CATH, 1304-CF-7-0.5(5)5-L-TE4BE1EB | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 88016 | K31133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |