BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS STREERABLE SHEATH

    MDR report key: 13982730 · Received April 1, 2022

    Report

    Report Number
    9710452-2022-00017
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 1, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    UDI-DI
    00685447005780
    PMA / PMN Number
    K190688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY. DHR REVIEW WAS COMPLETED FOR THE LOT IN QUESTION, AND IT WAS CONFIRMED THAT ALL DEVICES MET RELEVANT REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    A 20- MINUTE PROCEDURAL DELAY WAS REPORTED DURING A PROCEDURE DUE TO THE KINKING OF THE VERSACROSS STEERABLE SHEATH WHILE TRYING TO INSERT THE CATHETER INTO THE PATIENT'S GROIN. THE PROCEDURE WAS ABLE TO CONTINUE AFTER A NEW VERSACROSS STEERABLE SHEATH WAS OPENED AND USED. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE RESULTING PROCEDURAL DELAY THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013513 VERSACROSS STREERABLE SHEATH CATHETER, INTRODUCER DYB BAYLIS MEDICAL COMPANY INC. VST85-35-BD-71S-D1 VKFA230321 00685447005780

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other