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 2018-12-19 for TRUE FLOW PTV DILATATION CATHETER 0204511 manufactured by Bard Peripheral Vascular, Inc..
[130987336]
No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the device is pending. The investigation of the reported event is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[130987337]
It was reported that during preparation for a valvuloplasty procedure, the ptv balloon allegedly had a leak at the inflation hub. Another device was used to perform the procedure. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-02229 |
| MDR Report Key | 8182338 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-19 |
| 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 | BALLOON VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2019-01-08 |
| Model Number | 0204511 |
| Catalog Number | 0204511 |
| Lot Number | GFBN1147 |
| 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 | 2018-12-19 |