MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for TRUE DILATATION CATHETER 0244512 manufactured by Bard Peripheral Vascular, Inc..
[180367384]
The catalog number identified has not been cleared in the us, but is similar to the true dilatation balloon valvuloplasty products that are cleared in the us. The product classification code for the true dilatation balloon valvuloplasty product is identified. The lot number for the two malfunctions were provided and a lot history review was performed. The devices have been returned for evaluation; the evaluation unconfirmed fail to fold and retraction issue. Based upon the available information, a definitive root cause is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[180367385]
This report summarizes 2 malfunctions. A review of the reported information indicated that model 244512 true balloon valvuloplasty catheter allegedly experienced failure to fold and a retraction problem. This information was received from various sources. The two malfunctions involved two patients with no patient consequences. The age, weight, and genders of the two patients were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00185 |
| MDR Report Key | 9572523 |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-09 |
| 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 | 1415 W. 3RD STREET |
| 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 VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2020-01-09 |
| Model Number | 0244512 |
| Catalog Number | 0244512 |
| Lot Number | GFDQ1630, GFDR0526 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-09 |