FDA Adverse Event
Injury
Summary report: N
FLEXCATH STEERABLE SHEATH
MDR report key: 2192533
·
Received August 5, 2011
Report
- Report Number
- 3002648230-2011-00117
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 7, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- DRA
- PMA / PMN Number
- K081049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; NO EVALUATION COULD BE PERFORMED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
DURING A CRYOABLATION PROCEDURE USING THE ARCTIC FRONT CATHETER AND FLEXCATH STEERABLE SHEATH, A PERFORATION OCCURRED POSSIBLY NEAR THE RIPV WHILE ATTEMPTING TO OBTAIN OCCLUSION WITH THE ARCTIC FRONT CATHETER. THE CAUSE OF THE PERFORATION IS NOT KNOWN. THE PATIENT WAS TAKEN TO SURGERY. THE TEAR SEEMED TO SEAL ITSELF AND THE TEAR COULD NOT BE LOCATED BY THE SURGEON ON THE ANTERIOR SURFACE. THE ABLATION WAS COMPLETED IN THE OPERATING ROOM. THE PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXCATH STEERABLE SHEATH | CATHETER, STEERABLE | DRA | MEDTRONIC CRYOCATH LP | 3FC12 | 38075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |