BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX STEERABLE GUIDING SHEATH

    MDR report key: 11753014 · Received April 30, 2021

    Report

    Report Number
    9710452-2021-00027
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 30, 2021
    Product Code
    DYB
    UDI-DI
    90685447001679
    PMA / PMN Number
    K122926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT OCCURRED . DHR REVIEW WAS COMPLETED FOR THE LOT IN QUESTION AND ALL DEVICES MET RELEVANT REQUIRMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A 25-MINUTE PROCEDURAL DELAY WAS REPORTED IN CATHETER ABLATION PROCEDURE, WHERE THE SUREFLEX STEERABLE GUIDING SHEATH WAS USED AMONG OTHER DEVICES INCLUDING THE THERMOCOOL CATHETER (J&J) AND THE NRG TRANSSEPTAL NEEDLE. THE PROCEDURAL DELAY WAS DUE TO THE LOOSE SUREFLEX STEERABLE GUIDING SHEATH AND DILATOR HUB ASSEMBLY. A DIFFERENT STEERABLE SHEATH WAS USED TO CONTINUE THE PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653074 SUREFLEX STEERABLE GUIDING SHEATH CATHETER INTRODUCER DYB TSK85-32-BD-71S SSFH170720 90685447001679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other