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 2020-03-25 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-13 manufactured by Cardiovascular Systems, Inc..
[184904505]
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. Additional information has been requested regarding the cause of the patient's death and whether a csi device caused or contributed to it. However, no additional information has been received. The device history record for this oad 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. Csi id: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184904507]
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a severely calcified lesion with 95-99% stenosis located in the left main artery and extending into the ostial left anterior descending artery (lad). The oad was activated and advanced toward the target lesion. The oad made a loud pitch-changing noise and stopped spinning. The oad was removed from the patient, and contrast injection revealed a small perforation in the distal left main/ostial lad region. The patient experienced a drop in blood pressure and reduced left ventricular function. Balloon tamponade was attempted, and then three stents were deployed. Stent deployment successfully sealed the perforation. The patient stabilized, and impella support was left in place. The patient expired following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00089 |
| MDR Report Key | 9879476 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-25 |
| Model Number | DBEC-125 |
| Catalog Number | 70058-13 |
| Lot Number | 298158 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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; 2. Required No Informationntervention | 2020-03-25 |