BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBICATH STEERABLE SHEATH

    MDR report key: 2780634 · Received October 5, 2012

    Report

    Report Number
    2183787-2012-00077
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K101784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING PUNCTURED THE INTRA-ATRIAL SEPTUM WITH THE TRANSSEPTAL NEEDLE, THE PHYSICIAN TRIED TO PUSH THE DILATOR AND GUIDING SHEATH INTO THE LEFT ATRIUM BUT FELT SOME HEAVY RESISTANCE. THIS WAS THE PT¿S SECOND REDO ABLATION, WHICH MAY BE THE CAUSE OF THE RESISTANCE. HE MANAGED TO PUT THE SHEATH IN THE LEFT ATRIUM AND CHANGE THE MOBICATH SHEATH TO A PREFACE SHEATH, THROUGH WHICH HE INTRODUCED THE LASO INTO THE PT¿S LEFT ATRIUM. HE USED THE MOBICATH SHEATH AGAIN TO PUSH THROUGH THE SEPTUM AT THE PUNCTURE SITE, NEXT TO THE PREFACE SHEATH. AGAIN, HE FELT SOME RESISTANCE. HE COULD NOT MANAGE TO PUSH OVER THE DILATOR AND SEPTUM. HE TOOK THE MOBICATH OUT OF THE PT TO CHECK FOR ANY MALFUNCTION. THE TIP OF THE SHEATH WAS HEAVILY DEFORMED AND THERE WAS SOME TISSUE STICKING ON THE DEFORMED TIP OF THE SHEATH. THE PHYSICIAN CHANGED TO A SECOND PREFACE SHEATH WHICH HE COULD PLACE EASILY IN THE LEFT ATRIUM AND FINISHED THE PROCEDURE. FIFTEEN MINUTES AFTER WITHDRAWING THE CATHETERS, THE PT SHOW PECULIAR NEUROLOGICAL BEHAVIOR AND WAS BROUGHT TO EMERGENCY CT, WHERE A STROKE WAS DIAGNOSED. THE PHYSICIAN STATED THAT HE DOES NOT KNOW WHETHER THE INCIDENT WAS CAUSED BY THE MOBICATH SHEATH OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBICATH STEERABLE SHEATH STEERABLE SHEATH DYB GREATBATCH MEDICAL 1000182-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention