MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2020-01-15 for ULTRASCORE FOCUSED FORCE PTA BALLOON US141503H20 manufactured by Bard Peripheral Vascular, Inc..
[175083820]
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10
[175083821]
It was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, vessel dissection was identified in the pedal artery. It was further reported there was no medical intervention performed. Patient was discharged the same day as the procedure. New information: it was reported through the results of a clinical trial, that approximately 1-month and 26 days post angioplasty procedure, stenosis was identified in the pedal artery. It was further reported revascularization was performed using pta (non dcb).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00313 |
| MDR Report Key | 9592093 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-01-15 |
| 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 | FOCUSED FORCE PTA BALLOON |
| Product Code | PNO |
| Date Received | 2020-01-15 |
| Model Number | US141503H20 |
| Catalog Number | US141503H20 |
| Lot Number | GFDR1879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-15 |