FDA Adverse Event
Injury
Summary report: N
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
MDR report key: 3032722
·
Received April 3, 2013
Report
- Report Number
- 3002648230-2013-00051
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 6, 2013
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- OAE
- PMA / PMN Number
- P100010/S015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. FAILURE FILES WERE ANALYZED AND DO NOT SHOW ANY ERRORS OR SYSTEM NOTICES FOR THE DATE OF CASE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PATIENT UNDERWENT PULMONARY VEIN ISOLATION ON (B)(6) 2013. SEVERAL DAYS LATER, PATIENT PRESENTED TO PHYSICIAN WITH SYMPTOMATIC GASTROPARESIS VERIFIED BY EGD. PATIENT STABLE AND DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136677 | ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER | PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | MEDTRONIC CRYOCATH LP | 2AF284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Other |