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 2018-08-21 for TRUEFLOW BALLOON VALVULOPLASTY CATHETER TF0203511 manufactured by Bard Peripheral Vascular, Inc..
[117833289]
Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. Investigation summary: the investigation is inconclusive for the reported inflation issue, as the device was not returned for evaluation. The definitive root cause for the reported inflation issue could not be determined based upon available information. It is unknown whether procedural issues contributed to the event. Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 11/2019). 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
[117833310]
It was reported that during an aortic valvuloplasty, the ptv balloon allegedly had inflation issues. Another device was used to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-01515 |
| MDR Report Key | 7803609 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2018-08-21 |
| 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 | TRUEFLOW BALLOON VALVULOPLASTY CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2018-08-21 |
| Catalog Number | TF0203511 |
| Lot Number | GFBY2696 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-21 |