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 2020-03-17 for DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) manufactured by Cardiovascular Systems, Inc..
[183891230]
The site did not retain record of the lot number of the guide wire used, and the wire was discarded before the csi field rep could ask for its return. The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183891231]
The tip of the viperwire guide wire fractured during use in the right coronary artery (rca). The fragment was snared, and the out come of the case was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00084 |
| MDR Report Key | 9844795 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-17 |
| 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 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |