BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LP ACCESSORY KIT, TRANSVERSE SINUS INTRODUCER PKG

    MDR report key: 2063750 · Received April 14, 2011

    Report

    Report Number
    3003870001-2011-00001
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OCL
    PMA / PMN Number
    K080292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. IF THE DEVICE IS RETURNED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ATTEMPTING TO INSERT THE ULTRACINCH LP SIZER FOR A SURGICAL ATRIAL FIBRILLATION ABLATION PROCEDURE, A VENTRICULAR RUPTURE OCCURRED. THE ULTRACINCH LP SIZER WAS INSERTED VIA A RIGHT LATERAL THORACOTOMY INCISION THROUGH THE FOURTH INTERCOSTAL SPACE. THE PLACEMENT OF THE ULTRACINCH SIZER WAS DIFFICULT DUE TO THE PATIENT'S WEIGHT (B)(6) AND A LARGE AMOUNT OF FAT AROUND THE HEART. AFTER INSERTING THE SIZER THROUGH THE TRANSVERSE SINUS AROUND THE LEFT PULMONARY VEINS, THE PHYSICIAN ATTEMPTED TO PUSH IT THROUGH THE OBLIQUE SINUS BUT COULD NOT VISUALLY VERIFY THE POSITION OF THE SIZER AS THIS WAS A MINIMALLY INVASIVE PROCEDURE. DURING SIZING, THE VENTRICLE WAS "MECHANICALLY COMPROMISED" WHICH CAUSED IT TO SUDDENLY RUPTURE. IT WAS THEN DETERMINED THAT THE SIZER HAD BEEN PLACED OVER THE LEFT VENTRICLE INSTEAD OF BEHIND THE HEART AND THROUGH THE OBLIQUE SINUS. A STERNOTOMY WAS PERFORMED, THE PATIENT WAS CONNECTED TO THE HEART LUNG MACHINE, THE HOLE WAS CLOSED, AND THE ABLATION PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DIFFICULTY. THE PHYSICIAN ATTRIBUTES THE CAUSE FOR THE REPORTED RUPTURE TO THE PRESSURE THAT HE APPLIED TO THE SIZER AND INCORRECT PLACEMENT IN FRONT OF THE HEART RATHER THAN BEHIND IT. THE PHYSICIAN ALSO PLACED A SUTURE THROUGH THE TIP OF THE SIZER TO HAVE A GRIP ABLE EXTENSION TO DIRECT THE SIZER INTO THE RIGHT POSITION. TO ADVANCE THE SIZER BEHIND THE IVC, THE PHYSICIAN PULLED AT THE SUTURE FIRST UNTIL HE SAW THE SIZER TIP WHICH ALSO MAY HAVE ATTRIBUTED TO THE EVENT PER THE PHYSICIAN. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP ACCESSORY KIT, TRANSVERSE SINUS INTRODUCER PKG LP ACCESSORY KIT OCL ST. JUDE MEDICAL 12550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention