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 2019-01-15 for TRUE FLOW PTV DILATATION CATHETER TF0223512 manufactured by Bard Peripheral Vascular, Inc..
[133119194]
The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[133119195]
It was reported that during a balloon aortic valvuloplasty, the balloon allegedly had difficulty being inserted through the sheath. Another device was used to perform the procedure. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-02320 |
| MDR Report Key | 8249445 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-15 |
| Date of Report | 2019-03-26 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2017-12-22 |
| Date Added to Maude | 2019-01-15 |
| 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 | 1625 W 3RD ST. |
| 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 FLOW PTV DILATATION CATHETER |
| Generic Name | VALVULOPLASTY BALLOON |
| Product Code | OZT |
| Date Received | 2019-01-15 |
| Returned To Mfg | 2019-01-03 |
| Model Number | TF0223512 |
| Catalog Number | TF0223512 |
| Lot Number | GFBY2700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-15 |