BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1060783 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00688
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    THESE CODES WERE SELECTED BY THE MFR BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. BASED ON EVAL OF OTHER DEVICES THAT HAVE BEEN RETURNED WITH SIMILAR ISSUES, THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT THE TEETH OF THE LIGATOR HEAD BECAME DAMAGED DURING USE. WHEN THE TEETH BECOME DAMAGED, THE THREAD IS ABLE TO BE PULLED FREE FROM THE BAND, IT IS WRAPPED AROUND WITHOUT DEPLOYING THE BAND. AS SUBSEQUENT BANDS ARE DEPLOYED, THE PREVIOUSLY NON DEPLOYED BAND CAN BE DEPLOYED BY THE ACTION OF THE SUBSEQUENT BAND. THIS IS THE CAUSE OF MULTIPLE BANDS BEING DEPLOYED AT THE SAME TIME. THE CAUSE FOR THE TEETH BECOMING DAMAGED APPEARS TO BE A DESIGN ISSUE. THE TEETH ARE NOT STRONG ENOUGH TO ADEQUATELY HOLD THE KNOTS OF THE DEPLOYMENT THREAD IN PLACE. PULLING ON THE DEPLOYMENT THREAD CAUSES THE TEETH TO BECOME DAMAGED AND PREVENTS PROPER DEPLOYMENT OF THE BANDS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ISSUES THAT COULD BE ASSOCIATED WITH THIS EVENT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND 2 SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. A TOTAL OF 3 COMPLAINTS HAVE BEEN REPORTED FOR PRODUCT FROM THIS LOT. ALL 3 COMPLAINTS WERE REPORTED BY THE SAME CUSTOMER AND ARE BEING FILED UNDER MDR REFERENCE NUMBERS: (1) MDR REFERENCE NUMBER 3005099803-2008-00689 (2) MDR REF NUMBER: 3005099803-2008-00690.

    Description of Event or Problem · 1

    B3: DATE OF THE EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL VARICEAL BANDING, MULTIPLE BANDS CAME OFF THE SPEEDBAND SUPERVIEW SUPER 7 LIGATOR WHEN ONLY ONE WAS NEEDED. PATIENT WAS REPORTED TO BE DOING FINE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 11603440

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK