MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-04-03 for TRUE DILATATION CATHETER 0224512 manufactured by Bard Peripheral Vascular, Inc..
[104444242]
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 return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation. 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
[104444243]
It was reported that during preparation for a tavi procedure, the valvuloplasty balloon allegedly could not be aspirated with a luer lock syringe. The balloon was exchanged for another to perform the procedure. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
[119990727]
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. 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 device was returned for evaluation. A visual inspection under microscopic magnification found bubbles in the glue along the guidewire lumen in the hub. The device was aspirated and bubbles were seen entering the system from where the guidewire lumen and hub are joined. However, after approximately 10 min, air was no longer able to be aspirated into the system. Although, because air was seen to be initially aspirating along the guidewire lumen in the hub, the investigation is confirmed for the reported aspiration issue. Although all balloons are 100% tested at manufacturing for inflation, leaks, and visual anomalies at the hub using ultraviolet light, it is unknown how the returned device was able to aspirate air after inspection at manufacturing. Per the manufacturing review for the reported lot number, no changes in the manufacturing process were noted that would have contributed to the reported event. The definitive root cause for the reported aspiration issue could not be determined based upon available information. 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.
Patient Sequence No: 1, Text Type: N, H10
[119990728]
It was reported that during preparation for a tavi procedure, the valvuloplasty balloon allegedly could not be aspirated with a luer lock syringe. The balloon was exchanged for another to perform the procedure. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-00337 |
| MDR Report Key | 7394477 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-04-03 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2017-06-11 |
| Date Added to Maude | 2018-04-03 |
| 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 | BALLOON AORTIC VALVULOPLASTY |
| Product Code | OZT |
| Date Received | 2018-04-03 |
| Returned To Mfg | 2018-04-30 |
| Catalog Number | 0224512 |
| Lot Number | GFBT2028 |
| 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 | 2018-04-03 |