MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-12 manufactured by Cardiovascular Systems, Inc..
[185884408]
The opinion of the physician was that the entrapment of the device caused a blockage of blood flow, which contributed to the patient's death. However, 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 diamondback 360? Coronary orbital atherectomy system instructions for use manual lists slow flow and no reflow as a possible adverse event which can occur with use of the oas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185884409]
A diamondback coronary orbital atherectomy device (oad) was used to treat a high-risk patient. The patient had been turned down for surgery three times, and the chance of survival when undergoing percutaneous intervention was 50%. After atherectomy was begun, the device decelerated and became stuck in the lesion. Tremendous difficulty was experienced when removing the oad. A stent was deployed. The patient expired following the procedure. In the physician's opinion, the oad contributed to the patient's death because, having been stuck in the lesion, it occluded blood flow for an extended period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00101 |
| MDR Report Key | 9907876 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-10-17 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-31 |
| Model Number | DBEC-125 |
| Catalog Number | 70058-12 |
| Lot Number | 244825 |
| 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. Death | 2020-03-31 |