MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for TRUE DILATATION CATHETER 0284514 manufactured by Bard Peripheral Vascular, Inc..
[174601678]
For one of the two reported malfunctions, the device was returned to bd and identified for the material rupture. The other sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported malfunction is inconclusive for the second device. Based upon the available information, the definitive root cause for this event is unknown. The devices are labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[174601679]
This report summarizes two malfunctions. A review of the reported information indicated that model 0284514 pta balloon dilatation catheter allegedly experienced material rupture. This information was received from various sources. Of the 2 material ruptures, 2 involved patients with no patient consequences. There was no provided patient information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00188 |
| MDR Report Key | 9576566 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-01-10 |
| 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 | TRUE DILATATION CATHETER |
| Generic Name | PTA BALLOON DILATATION CATHETER |
| Product Code | OZT |
| Date Received | 2020-01-10 |
| Model Number | 0284514 |
| Catalog Number | 0284514 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| 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 | 2020-01-10 |