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 2020-03-18 for DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) VPR-GW-FLEX14 7-10041-03 manufactured by Cardiovascular Systems, Inc..
[184056998]
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184056999]
The viperwire guide wire was advanced as far forward as was possible in order to treat a distal lesion in the anterior tibial artery near the ankle. The lesions were severely calcified, and the vessel was tortuous. The guide wire fractured during use, though it is unclear whether the physician spun over the tip of the wire or not. Surgery was performed to remove the fragment. While not all planned treatment could be performed due to the fracture and subsequent surgery, the physician remarked that the pedal pulse was good following the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00087 |
| MDR Report Key | 9847891 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-03-18 |
| 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 | MORGAN HILL |
| Manufacturer Street | 1225 OLD HWY 8 NW |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HWY 8 NW |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) |
| Generic Name | PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE) |
| Product Code | MCW |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-04 |
| Model Number | VPR-GW-FLEX14 |
| Catalog Number | 7-10041-03 |
| Lot Number | 277253 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HWY 8 NW ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |