FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 7 XB
MDR report key: 3832318
·
Received February 10, 2014
Report
- Report Number
- 2242352-2014-00070
- Event Type
- Malfunction
- Date Received
- February 10, 2014
- Date of Event
- January 14, 2014
- Report Date
- January 15, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR SOPS, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THEY HAD TWO SEPARATE BALLOON PORTS BURST. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS AND NOTHING FELL INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87591 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR LLC | VH-3200 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |