MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for DIAMONDBACK PERIPHERAL DBP-200SOLID145 7-10057-04 manufactured by Cardiovascular Systems, Inc..
[183517378]
From staff: surgeon went to perform coronary stent implantation atherectomy on right leg; circulating rn passed coronary stent implantation device to surgeon following sterile guidelines. Coronary stent implantation machine was primed and inserted into right leg and used. Surgeon stated that the machine wasn't working properly, however did not know exactly what wasn't working properly. Team switched out coronary stent implantation device and had no other problems with atherectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9835001 |
| MDR Report Key | 9835001 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-26 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMONDBACK PERIPHERAL |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-16 |
| Model Number | DBP-200SOLID145 |
| Catalog Number | 7-10057-04 |
| Lot Number | 266811 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HIGHWAY 8 NW SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |