MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for VASCUTRAK PTA DILATATION CATHETER V184040 manufactured by Bard Peripheral Vascular, Inc..
[179403892]
The lot number for the malfunction was provided and a lot history review was performed. The device was returned for evaluation; the investigation was confirmed for the reported balloon rupture, as a longitudinal rupture was noted to the balloon. The investigation was also confirmed for core wire break, as a break was noted to core wire. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[179403893]
This report summarizes one malfunction. A review of the reported information indicated that model v184040 vascutrak pta dilatation catheter allegedly experienced balloon longitudinal material rupture and break. This information was received from one source. Of the one balloon longitudinal material rupture malfunction, one patient was involved with no patient consequence or impact. Patient's age, weight, and gender was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00422 |
| MDR Report Key | 9594168 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2019-12-31 |
| 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 DILATATION CATHETER |
| Generic Name | PTA BALLOON DILATATION CATHETER |
| Product Code | PNO |
| Date Received | 2020-01-15 |
| Model Number | V184040 |
| Catalog Number | V184040 |
| Lot Number | GFDR4288 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-15 |