MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-16 for VASOVIEW 6 PRO VH-2400 NA manufactured by Maquet Cardiovascular, Llc.
[46471280]
The device has not yet been returned to maquet cardiac surgery for evaluation. 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 recorded in the lot history. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46471281]
The hospital reported that during an endoscopic vein harvesting procedure, the irrigation port was defective. The device was subsequently taken off the field. It is unknown if the product will be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2013-01882 |
| MDR Report Key | 5695307 |
| Date Received | 2014-01-16 |
| Date of Report | 2013-12-27 |
| Date of Event | 2013-12-04 |
| Date Mfgr Received | 2013-12-27 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097690 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VASOVIEW 6 PRO |
| Generic Name | ENDOSCOPIC VESSEL HARVESTING |
| Product Code | OSV |
| Date Received | 2014-01-16 |
| Model Number | VH-2400 |
| Catalog Number | NA |
| Lot Number | 25087616 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-16 |