FDA Adverse Event
Malfunction
Summary report: N
MERCI BALLOON GUIDE CATHETER 9F X 95 CM
MDR report key: 2271385
·
Received September 16, 2011
Report
- Report Number
- 2954917-2011-00019
- Event Type
- Malfunction
- Date Received
- September 16, 2011
- Date of Event
- August 25, 2011
- Report Date
- September 16, 2011
- Manufacturer
- CONCENTRIC MEDICA, INC.
- Product Code
- DQY
- PMA / PMN Number
- 010954
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS NOT ABLE TO DEFLATE A BALLOON GUIDE CATHETER 9F, 95 CM IN THE INTERNAL CAROTID ARTERY (ICA) OF A (B)(6) FEMALE PT. AFTER INFUSING SALINE INTO THE BALLOON, THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON. THE VESSEL OPENED UP WITHOUT ANY ISSUES. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS WARNINGS THAT PROVIDED RECOMMENDATIONS TO REDUCE RISK OF COMPLICATIONS DUE TO SLOW BALLOON DEFLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCI BALLOON GUIDE CATHETER 9F X 95 CM | CATHETER, PERCUTANEOUS | DQY | CONCENTRIC MEDICA, INC. | 90074 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |