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 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) GWC-12325LG-FT 7-10038-01 manufactured by Cardiovascular Systems, Inc..
[183013526]
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 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. The user facility report ((b)(4)) was received 3 march 2020. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183013527]
An orbital atherectomy device (oad) and viperwire guide wire were selected for treatment of a chronic total occlusion lesion in the left anterior descending artery (lad), which was extremely tortuous. The physician stated the orbital atherectomy device (oad) stalled during use and was not subintimal. The oad was stuck in the lesion and stuck on the viperwire. During removal attempts, the oad and wire were pulled on forcefully to remove them from the patient. The tip of the viperwire broke off at that time. The fragment remained in the patient when the oad and wire were removed. Wire access was lost during removal. Attempts to snare the tip were unsuccessful, and a stent was deployed. The stent covered the proximal side of the fragment. The procedure was completed, and the patient was transferred to the cardiac care unit. On (b)(6) 2020, risk management communicated to csi field staff that the patient expired overnight. The physician did not provide cause of death but stated the issues relating to the wire fracture may have contributed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00075 |
| MDR Report Key | 9820675 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-11-01 |
| 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 | 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 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-11 |
| Model Number | GWC-12325LG-FT |
| Catalog Number | 7-10038-01 |
| Lot Number | 295970 |
| 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. Other | 2020-03-11 |