BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    MDR report key: 8184785 · Received December 20, 2018

    Report

    Report Number
    9710452-2018-00044
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 20, 2018
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K102948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE BAYLIS MEDICAL DEVICE WAS NOT USED IN A PATIENT. HOWEVER, THE REPORT IS BEING SUBMITTED AS THE PROBLEM WAS NOTED WHEN BROCKENBROUGH CURVED NEEDLE (MEDTRONIC EP003994S) WAS INSERTED INSIDE THE BAYLIS MEDICAL TORFLEX DILATOR.

    Description of Event or Problem · 1

    THE TORFLEX TRANSSEPTAL GUIDING SHEATH WAS BEING PREPARED FOR USE IN A PROCEDURE. WHEN INTRODUCING A BROCKENBROUGH CURVED NEEDLE (MEDTRONIC EP003994S) INSIDE THE TORFLEX DILATOR OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED SKIVING FROM THE DILATOR. THE SUBJECT DEVICE WAS NOT USED IN A PATIENT AND THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE BAYLIS MEDICAL DEVICE WAS NOT USED IN A PATIENT. HOWEVER, THE REPORT IS BEING SUBMITTED AS THE PROBLEM WAS NOTED WHEN BROCKENBROUGH CURVED NEEDLE (MEDTRONIC EP003994S) WAS INSERTED INSIDE THE BAYLIS MEDICAL TORFLEX DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022943 TORFLEX TRANSSEPTAL GUIDING SHEATH CATHETER INTRODUCER DYB BAYLIS MEDICAL COMPANY INC. TF85-32-63-55 TFFJ200918

    Patients

    Seq Age Sex Outcome Treatment
    1