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 DBEC-125 manufactured by Cardiovascular Systems, Inc..
[182982027]
(b)(4). Since no imaging was performed between angioplasty and atherectomy, it is unclear whether there was a post-angioplasty issue that caused or contributed to the event. It is also unclear whether the csi device contributed to or caused the event. The physician's opinion was requested, but did he not provide one. 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. If the lot number is provided, a dhr review will be performed. Lot number, specific cause of the patient's death, and additional case details were requested, but they have not been provided. If the information is provided, a supplemental report will be sent. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182982028]
A diamondback coronary orbital atherectomy device (oad) was selected for treatment. Prior to atherectomy, aggressive angioplasty was performed. Ejection fraction was not recorded after angioplasty; the physician moved on to atherectomy immediately. Thereafter, the patient deteriorated. Imaging did not indicate dissection or perforation of the vessel. The patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00072 |
| MDR Report Key | 9819398 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-04 |
| 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 |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-11 |
| 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 HWY 8 NW ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-11 |