FDA Adverse Event
Malfunction
Summary report: N
ENROUTE,ST,MOD,S,HY,US 95-014
MDR report key: 16032538
·
Received December 22, 2022
Report
- Report Number
- 3006010712-2022-00057
- Event Type
- Malfunction
- Date Received
- December 22, 2022
- Date of Event
- November 30, 2022
- Report Date
- January 18, 2023
- Manufacturer
- LAKE REGION MEDICAL
- Product Code
- DQX
- UDI-DI
- 00811311020546
- PMA / PMN Number
- K160643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT INVESTIGATION UNDERWAY.
Additional Manufacturer Narrative · 0
COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.
Description of Event or Problem · 0
SILK ROAD MEDICAL WAS MADE AWARE ON SEPTEMBER 09, 2022, THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS CAUSED BY 0.014" ENROUTE GUIDEWIRE. THE DISSECTION WAS RESOLVED WITH HEPARIN REVERSAL.
Description of Event or Problem · 0
SILK ROAD MEDICAL WAS MADE AWARE ON SEPTEMBER 09, 2022, THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS CAUSED BY 0.014" ENROUTE GUIDEWIRE. THE DISSECTION WAS RESOLVED WITH HEPARIN REVERSAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2917959 | ENROUTE,ST,MOD,S,HY,US 95-014 | ENROUTE,ST,MOD,S,HY,US 95-014 | DQX | LAKE REGION MEDICAL | 901047-01 | 6902023 | 00811311020546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |