BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE,ST,MOD,S,HY,US 95-014

    MDR report key: 15453319 · Received September 20, 2022

    Report

    Report Number
    3006010712-2022-00041
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 2, 2022
    Report Date
    October 11, 2022
    Manufacturer
    BRIVANT LIMITED
    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 AND WILL BE ATTACHED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE ON 02SEP2022, A PERFORATION WAS IDENTIFIED IN THE COMMON CAROTID ARTERY (CCA) AT THE END OF THE ENROUTE NEUROPROTECTION SYSTEM (NPS) SHEATH WHILE USING THE 0.014" ENROUTE INTERVENTIONAL WIRE. THE CCA WAS REPAIRED WITH A SUTURE. THE PROCEDURE WAS COMPLETED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE ON (B)(6) 2022, A PERFORATION WAS IDENTIFIED IN THE COMMON CAROTID ARTERY (CCA) AT THE END OF THE ENROUTE NEUROPROTECTION SYSTEM (NPS) SHEATH WHILE USING THE 0.014" ENROUTE INTERVENTIONAL WIRE. THE CCA WAS REPAIRED WITH A SUTURE. THE PROCEDURE WAS COMPLETED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645372 ENROUTE,ST,MOD,S,HY,US 95-014 ENROUTE,ST,MOD,S,HY,US 95-014 DQX BRIVANT LIMITED 901047-01 5688825 00811311020546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown