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 2020-03-10 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM VPR-GW-FLEX14 7-10041-03 manufactured by Cardiovascular Systems, Inc..
[184425795]
The reported guide wire was returned for analysis along with the oad used during the procedure. The guide wire was observed to be fractured at two locations with multiple kinks located on the wire shaft. The distal spring tip was confirmed to be detached. Scanning electron microscopy was performed and identified evidence of fatigue and rotational surface damage at the site of the proximal core wire fracture. This damage is consistent with an oad being spun over a kinked section of the guide wire. Microscopy was also performed at the site of the distal spring tip fracture and found that the support ribbon was displaced and partially separated from the adhesive bond. Fatigue striations were also noted, suggesting the fracture may have been the result of an elevated stress environment. Though the reported wire fracture was confirmed through analysis, the root cause could not be determined. The material inspection report for this guide wire lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements prior to distribution. Csi id: 08268
Patient Sequence No: 1, Text Type: N, H10
[184425796]
A peripheral diamondback exchangeable orbital atherectomy device (oad) was used to treat a heavily calcified, 80% stenosed lesion in the superficial femoral artery (sfa). The oad was removed and balloon angioplasty was performed over the viperwire guide wire. When the wire was removed and reinserted in order to treat a second lesion in the anterior tibial artery, it was noted that the wire had fractured and a fragment remained inside the sfa, popliteal and peroneal. Multiple attempts were made to snare the wire fragment. The fragment was unable to be snared and was removed surgically. The patient was in stable condition following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00068 |
| MDR Report Key | 9812482 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-02-13 |
| Model Number | VPR-GW-FLEX14 |
| Catalog Number | 7-10041-03 |
| Lot Number | 292553 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-10 |