BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 81 CM LENGTH, 8.5F

    MDR report key: 8939339 · Received August 28, 2019

    Report

    Report Number
    3005334138-2019-00469
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    March 17, 2010
    Report Date
    September 30, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS RECEIVED INDICATING THIS EVENT WAS A DUPLICATE AND REPORTED IN MANUFACTURER REFERENCE NUMBER 3005188751-2010-00024.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF SHEATH TIP DETACHMENT COULD NOT BE CONFIRMED. AN EVENT OF MEDICAL INTERVENTION WAS ALSO REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DETACHMENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS IN AN ARTICLE TITLED "DETACHED TIP OF A TRANSSEPTAL SHEATH DURING LEFT ATRIAL ABLATION" BY EL-DAMATY ET AL. 2011. 79:444 "WE REPORT A SIMILAR OCCURRENCE WITH AN SL-1 TRANSSEPTAL SHEATH, 8.5F, 63 CM, MODEL NUMBER 407454 (ST. JUDE MEDICAL, MINNEAPOLIS, MN) DURING A LEFT ATRIAL FLUTTER ABLATION PROCEDURE, WITH SUCCESSFUL REMOVAL OF THE DETACHED SEGMENT UTILIZING A NOVEL APPROACH OF RETRIEVAL. SHORTLY AFTER BEGINNING AN ACTIVATION MAP OF THE LA, THE RADIOPAQUE TIP OF THE SHEATH WAS THEN SEEN COMPLETELY DETACHED FROM THE REST OF THE SHEATH AND FLOATING IN THE LA. AT FIRST, THE DETACHED SEGMENT WAS FREELY MOBILE BUT THEN LODGED AT THE LOWER PART OF THE ANTERIOR LEFT ATRIAL SEPTUM. THE ABLATION CATHETER WAS WITHDRAWN; A WIRE WAS ADVANCED THROUGH THE SL-1 SHEATH, WHICH WAS EXCHANGED FOR AN AGILISTM NXT STEERABLE SHEATH (ST. JUDE MEDICAL, MINNEAPOLIS, MN). THE ABLATION PROCEDURE WAS ABORTED AND THE PATIENT WAS CARDIOVERTED TO SINUS RHYTHM USING A SYNCHRONIZED 300 J BIPHASIC SHOCK. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT WITH NO COMPLICATIONS. THE FLUOROSCOPIC TIME WAS 70 MIN. THE PATIENT WAS DISCHARGED TWO DAYS LATER IN GOOD CONDITION AFTER ACHIEVING A THERAPEUTIC INTERNATIONAL NORMALIZED RATIO. THE ROOT CAUSE OF THIS MALFUNCTION WAS FOUND TO BE LACK OF A SECONDARY BONDING PROCESS THAT THESE SHEATHS GENERALLY UNDERGO DURING THE MANUFACTURING PROCESS. THE SHEARING FORCE BETWEEN THE SHEATH AND THE INTERATRIAL SEPTUM DURING THE TRANSSEPTAL PUNCTURE MIGHT HAVE TRIGGERED DISLODGMENT OF THE ALREADY DEFECTIVE TIP." DOI 10.1002/CCD.23168.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736841 SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 81 CM LENGTH, 8.5F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 407453

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR