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 2020-03-11 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM VPR-GW-FLEX14 7-10041-03 manufactured by Cardiovascular Systems, Inc..
[182938521]
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182938522]
A peripheral orbital atherectomy device (oad) was used to treat a lesion in the posterior tibial artery (pt). A pinch pulling method was used to remove the oad from the patient, which resulted in the viperwire guide wire moving back into the proximal superficial femoral artery (sfa). A non-csi catheter was then used to cross the pt, during which the tip of the viperwire protruded through the side of the catheter. A technician attempted to remove the viperwire, but stopped the attempt upon feeling resistance. The physician then pulled hard on the wire, causing it to stretch and the tip to fracture. The wire fragment was snared and removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00071 |
| MDR Report Key | 9817989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-11 |
| 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 | MRS. LARAMIE OTTO |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | ST. PAUL, MN, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 2591600 |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | ST. PAUL, MN, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | PERIPHERAL ATHERECTOMY DEVICE |
| Product Code | MCW |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-03 |
| Model Number | VPR-GW-FLEX14 |
| Catalog Number | 7-10041-03 |
| Lot Number | 293806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HIGHWAY 8 NW ST. PAUL, MN, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |