BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1964145 · Received January 19, 2011

    Report

    Report Number
    3005099803-2011-00170
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE, THEREFORE THE DATE OF MANUFACTURE AND DATE OF EXPIRY ARE UNKNOWN. INVESTIGATION RESULTS - A SEARCH OF THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS REVEALED NO ADVERSE TRENDS FOR THIS DEFECT TYPE. THE HANDLE AND LIGATOR HEAD WERE RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND 6 BANDS WERE OVERLAPPING BUT REMAINED IN TACT ON THE LIGATOR HEAD ASSEMBLY. IT WAS ALSO NOTED THE TEETH ON THE LIGATOR HEAD WERE DAMAGED. THE DEPLOYMENT THREAD WAS ATTACHED TO THE DISTAL END OF THE TRIP WIRE HOWEVER WAS SEPARATED FROM THE LIGATOR HEAD. THE SUTURE DETACHMENT FOUND WAS MOST LIKELY DUE TO REMOVAL OF THE LIGATOR HEAD FROM THE SCOPE AFTER THE PROCEDURE WAS COMPLETED. THERE WERE TWO KINKS NOTED ON THE TRIP WIRE WHICH ARE LIKELY DUE TO ANATOMICAL/PROCEDURAL/OPERATIONAL FACTORS ENCOUNTERED DURING PROCEDURE. THE TRIP WIRE WAS WRAPPED AROUND THE DRUM INDICATING THE HANDLE HAD BEEN TURNED TO DEPLOY THE BAND. A FUNCTIONAL TEST WAS PERFORMED AND THE HANDLE WAS ABLE TO BE TURNED TO TAKE UP SLACK IN THE TRIP WIRE AND AN AUDIBLE CLICK WAS HEARD WITH EACH TURN. IT WAS ALSO NOTED THE TRIP WIRE WAS ABLE TO BE CINCHED IN THE HANDLE ASSEMBLY. THE INVESTIGATION RESULTS WERE NOT ABLE TO CONFIRM THE CUSTOMER'S COMPLAINT THAT NO CLICKING WAS HEARD DURING BAND DEPLOYMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPER 7 WAS USED TO BAND A VARIX IN THE ESOPHAGUS DURING A PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE SPEEDBAND WAS POSITIONED WITHIN THE ESOPHAGUS, THE HANDLE WAS ROTATED AND THE BANDS WERE DEPLOYED. THE ONLY REPORTED MALFUNCTION WAS WHEN THE HANDLE WAS ROTATED THERE WAS NO CLICKING NOISE HEARD. THE SPEEDBAND IS DESIGNED TO CREATE AND AUDIBLE CLICK TO INDICATE RELEASE OF A BAND, HOWEVER THE DEVICES FAILURE TO CLICK HAD NO EFFECT ON BAND DEPLOYMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS SPEEDBAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE. INVESTIGATION RESULTS ON THE RETURNED DEVICE REVEALED THE TEETH ON THE LIGATOR HEAD WERE DAMAGED. THIS IS CONTRARY TO THE INITIAL REPORT THAT THE ONLY MALFUNCTION OR DEFECT WAS THE LACK OF CLICKING DURING BAND DEPLOYMENT. BASED ON THE DEVICE EVALUATION, THIS COMPLAINT HAS BEEN DEEMED A MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX SCOPE