FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 7 XB
MDR report key: 3897142
·
Received May 21, 2014
Report
- Report Number
- 2242352-2014-00595
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Report Date
- April 24, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDS IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT THE BALLOON ON THE VASOVIEW 7 XB RUPTURED. THE HOSP DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304017 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3200 | 25092644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |