FDA Adverse Event
Malfunction
Summary report: N
COOL PATH F7, 1340-CP-7-25-L-AB (USA)
MDR report key: 1883201
·
Received October 20, 2010
Report
- Report Number
- 2030404-2010-00198
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 2010
- Manufacturer
- ST. JUDE MEDICAL IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 10/20/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(4) 2010.
Description of Event or Problem · 1
IT WAS REPORTED SEVERAL HOURS INTO AN ABLATION PROCEDURE SALINE WAS LEAKING FROM THE HANDLE OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH F7, 1340-CP-7-25-L-AB (USA) | NONE | OAD | ST. JUDE MEDICAL IRVINE | 84309 | K28980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |