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 2020-03-12 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 manufactured by Cardiovascular Systems, Inc..
[183087152]
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 device history record for the reported oad was unable to be reviewed, as the lot number was not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183087153]
The diamondback coronary orbital atherectomy device (oad) was selected for treatment in an elderly patient with advanced heart disease and severely calcified arteries in a last attempt to open the left anterior descending artery. Prior to the procedure an impella device was placed in the patient. Multiple attempts with balloons were made to cross the proximal side of the lad, but were unsuccessful, and the oad was selected for treatment. The oad was operated on low speed for a few treatment passes. A vessel perforation was identified on the distal left main artery, extending to the proximal side of the lad. Stent placement was performed, and cardiopulmonary resuscitation was administered via a lucas device, however the patient expired. Per the opinion of the physician, the cause of death was the perforation and inability to perfuse the left side of the heart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00073 |
| MDR Report Key | 9823215 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-12 |
| 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 | BRITTANY LEIDER |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 2591600 |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT 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 |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-12 |
| Model Number | DBEC-125 |
| 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 HIGHWAY 8 NW SAINT PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-03-12 |