FDA Adverse Event
Injury
Summary report: N
EVERCROSS¿ .035" OTW PTA DILATATION CATHETER
MDR report key: 2402090
·
Received January 6, 2012
Report
- Report Number
- 2183870-2012-00001
- Event Type
- Injury
- Date Received
- January 6, 2012
- Date of Event
- December 2, 2011
- Report Date
- December 6, 2011
- Manufacturer
- EV3 INC.
- Product Code
- DQY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.
Description of Event or Problem · 1
THIS PROCEDURE WAS PERFORMED IN (B)(6). THE PHYSICIAN INFLATED THE BALLOON INSIDE THE ARTERY, AND AT 12ATM THE BALLOON BROKE. WHEN THE PHYSICIAN RETRIEVED THE BALLOON, ONLY ONE PART OF IT CAME OUT, THE OTHER PART OF THE CATHETER AND BALLOON STAYED IN THE ARTERY. IT WAS NECESSARY TO USE A SNARE TO RETRIEVE THE SECOND PART OF THE BALLOON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVERCROSS¿ .035" OTW PTA DILATATION CATHETER | CATHETER, PERCUTANEOUS | DQY | EV3 INC. | AB35W08040080 | 9500667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | COOK SHEATH |