FDA Adverse Event
Injury
Summary report: N
FREEZOR CARDIAC XTRA SURGICAL CRYOABLATION DEV
MDR report key: 653102
·
Received December 15, 2005
Report
- Report Number
- 3002648230-2005-00009
- Event Type
- Injury
- Date Received
- December 15, 2005
- Date of Event
- November 28, 2005
- Report Date
- December 15, 2005
- Manufacturer
- CRYOCATH TECHNOLOGIES, INC.
- Product Code
- NFC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PT UNDERGOING ABLATION FOR AVNRT DURING FIRST MAPPING OF NODE LESS THAN 40 SECONDS CRYOMAP DURING WHICH 2:1 BLOCK AND THEN COMPLETE HEART BLOCK OCCURRED. THE PROCEDURE WAS THEN TERMINATED. TWO DAYS LATER THE PT WAS STILL IN CHB WITH NARROW JUNCTIONAL ESCAPE RHYTHM IN HIGH 50'S WITH EXERTIONAL FATIGUE. A PERMANENT PACEMAKER WAS IMPLATED. THE DEVICE DID NOT MALFUNCTION BUT ITS CONTRIBUTION CANNOT BE RULED OUT. THE EVENT CONSTITUTES A SERIOUS INJURY BECAUSE THE ABLATION WAS TERMINATED EARLY AND FURTHER MEDICAL INTERVENTION WAS REQUIRED: PERMANENT PEACEMAKER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEZOR CARDIAC XTRA SURGICAL CRYOABLATION DEV | CADIOVASCULAR DEVICE (CRYOCATHETER) | NFC | CRYOCATH TECHNOLOGIES, INC. | 227F3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |