MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-15 for VASCUTRAK PTA BALLOON DILATATION CATHETER V1425300 manufactured by Bard Peripheral Vascular, Inc..
[178785475]
No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a lot history will be performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 08/2022).
Patient Sequence No: 1, Text Type: N, H10
[178785476]
It was reported that during an angioplasty procedure in the lower left extremity, the pta balloon allegedly had deflation issues. A needle stick was used to percutaneously deflate the balloon. Another device was used to complete the procedure. There were no further complications to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-05928 |
| MDR Report Key | 9593812 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-15 |
| 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 | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCUTRAK PTA BALLOON DILATATION CATHETER |
| Generic Name | PTA BALLOON DILATATION CATHETER |
| Product Code | PNO |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2019-12-27 |
| Model Number | V1425300 |
| Catalog Number | V1425300 |
| Lot Number | GFDV2802 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |