FDA Adverse Event
Injury
Summary report: N
FREEZER CARDIAC CRYOABLATING CATHETER
MDR report key: 653106
·
Received December 15, 2005
Report
- Report Number
- 3002648230-2005-00008
- Event Type
- Injury
- Date Received
- December 15, 2005
- Date of Event
- November 15, 2005
- Report Date
- December 15, 2005
- Manufacturer
- CRYOCATH TECHNOLOGIES, INC.
- Product Code
- NFC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PATIENT UNDERGOING ABLATION FOR AVNRT HAD A BRIEF HEART BLOCK DURING MAPPING DUE TO CATHETER MANIPULATION, THEN HAD ANOTHER HEART BLOCK DURING CRYOABLATION. THE PROCEDURE WAS INTERRUPTED. 2:1 CONDUCTION RETURNED IN ABOUT AN HOUR AND COMPLETE AV CONDUCTION RETURNED IN ABOUT FOUR (4) HOURS. THE PT WAS DOING WELL AND NO PACEMAKER WAS REQUIRED. THE DEVICE DID NOT MALFUNCTION BUT ITS CONTRIBUTION CANNOT BE RULED OUT. THE EVENT CONSTITUTES A SERIOUS INJURY BECAUSE THE ABLATION PROCEDURE WAS TERMINATED PRIOR TO COMPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEZER CARDIAC CRYOABLATING CATHETER | CADIOVASCULAR DEVICE (CRYOCATHETER) | NFC | CRYOCATH TECHNOLOGIES, INC. | 217F3 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Other |