MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for ENROUTE 0.014" GUIDEWIRE SR-014-GW manufactured by Lake Region Medical.
[188983855]
During a tcar procedure, a small interventional wire dissection in the right common carotid artery occurred. The sheath was repositioned, and the wire was then advanced into the true lumen. The tcar procedure was completed, as planned, and then a stent was placed in the right common carotid artery to tack down the dissection. Patient was stable at the end of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00046 |
| MDR Report Key | 9858289 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-25 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2020-03-19 |
| Date Reported to FDA | 2020-03-19 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE 0.014" GUIDEWIRE |
| Generic Name | 0.014" GUIDEWIRE |
| Product Code | DQX |
| Date Received | 2020-03-20 |
| Model Number | SR-014-GW |
| Catalog Number | SR-014-GW |
| Lot Number | 4661646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | PARKMORE WEST BUSINESS PARK GALWAY, 091385037 EI 091385037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |