FDA Adverse Event
Injury
Summary report: N
VASOVIEW 7XB
MDR report key: 1586181
·
Received January 22, 2010
Report
- Report Number
- 2648729-2009-00144
- Event Type
- Injury
- Date Received
- January 22, 2010
- Date of Event
- December 30, 2009
- Report Date
- December 30, 2009
- Manufacturer
- MAQUET PUERTO RICO, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K041981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO CARDIAC SURGERY IN 2010 FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-2004 SHORT PORT BTT BALLOON RUPTURED LEAVING LITTLE PIECES IN THE PT'S LEG. ALL THE PIECES WERE RETRIEVED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT THE UNIT. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW 7XB | VV7XB BTT SHORT PORT | GCJ | MAQUET PUERTO RICO, LLC | VH-2004 | 9070972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |