MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-05-03 for VIDA PTV CATHETER VDA100166 manufactured by Bard Peripheral Vascular, Inc..
[44339976]
Manufacturing review: a complete manufacturing review could not be conducted as the lot number is unknown. Visual inspection: as the sample was not returned for evaluation, a visual inspection could not be performed. Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. The definitive root cause could not be determined based upon the available information. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current vida ptv catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
Patient Sequence No: 1, Text Type: N, H10
[44339977]
It was reported that while treating a venous anastomosis the pta balloon allegedly ruptured at 12 atm on the first inflation. Reportedly, there was no retraction issues. There was no additional treatment provided. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00420 |
| MDR Report Key | 5629449 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2016-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 WEST 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | FUTUREMATRIX INTERVENTIONAL |
| Manufacturer Street | 1605 ENTERPRISE STREET |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75751 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDA PTV CATHETER |
| Generic Name | PTA DILATATION BALLOON CATHETER |
| Product Code | OMZ |
| Date Received | 2016-05-03 |
| Catalog Number | VDA100166 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |