MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for ULTRASCORE FOCUSED FORCE PTA BALLOON US14150420 manufactured by Bard Peripheral Vascular, Inc..
[180118873]
The lot number for the malfunction was provided and a lot history review was performed. The device has not been returned for evaluation; therefore, the investigation is inconclusive for the retraction problem and device-device incompatibility as no objective evidence has been provided to confirm any alleged deficiency with the device. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[180118894]
This report summarizes one malfunction. A review of the reported information indicated that model us14150420 pta balloon dilatation catheter allegedly experienced device-device incompatibility and retraction problem. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The (b)(6) month old male patient was (b)(6) kg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00222 |
| MDR Report Key | 9587141 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-14 |
| 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 | ULTRASCORE FOCUSED FORCE PTA BALLOON |
| Generic Name | PTA BALLOON DILATATION CATHETER |
| Product Code | PNO |
| Date Received | 2020-01-14 |
| Model Number | US14150420 |
| Catalog Number | US14150420 |
| Lot Number | GFDN3797 |
| 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 | 2020-01-14 |