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 2018-05-07 for TRUE DILATATION CATHETER 0224512 manufactured by Bard Peripheral Vascular, Inc..
[107570193]
No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device was returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[107570194]
It was reported that the valvuloplasty balloon allegedly would not hold the pressure throughout inflation. It was further reported that the balloon was removed from the patient and an attempt to inflate it on the back table allegedly discovered a pin hole rupture at the distal portion of the balloon. Reportedly, the procedure was completed with another valvuloplasty balloon. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-00584 |
| MDR Report Key | 7492609 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-07 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2018-05-07 |
| 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 DILATATION CATHETER |
| Generic Name | VALVULOPLASTY BALLOON |
| Product Code | OZT |
| Date Received | 2018-05-07 |
| Returned To Mfg | 2018-04-20 |
| Catalog Number | 0224512 |
| Lot Number | GFBW2953 |
| 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 | 2018-05-07 |