BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPER VIEW SUPER 7

    MDR report key: 914792 · Received September 18, 2007

    Report

    Report Number
    6000048-2007-00289
    Event Type
    Injury
    Date Received
    September 18, 2007
    Date of Event
    August 22, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION. A ANALYSIS WILL NOT BE PERFORMED; THEREFORE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE REPORTED EVENT IS UNKNOWN. THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED; THEREFORE, THE CUSTOMER'S SHIPMENT HISTORY WAS REVIEWED TO IDENTIFY A POTENTIAL LOT NUMBER FOR THE SUSPECT DEVICE. THREE OF THE MOST RECENT LOTS SHIPPED TO THE CUSTOMER, PRIOR TO THE REPORTED INCIDENT, WERE IDENTIFIED AS: 8064170, 8965019, AND 8942263. THE DEVICE HISTORY RECORD FOR EACH OF THESE LOTS WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED ONE ADDITIONAL COMPLAINT REPORTED FOR LOT NUMBER 8965019; FOR AN UNRELATED EVENT (BENT TRIP WIRE). NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR EITHER OF THE OTHER TWO LOTS. THE JULY 2007 15-MONTH BAND LITIGATION PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007, THAT A SPEEDBAND SUPER VIEW SUPER 7 LIGATOR WAS USED DURING A VARICEAL BANDING PROCEDURE WITHIN THE ESOPHAGUS ON AN ADULT MALE PATIENT (AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS AWARE THE SPEEDBAND DEVICE WAS BEYOND ITS EXPIRATION DATE YET CONTINUED WITH THE PROCEDURE. THE PATIENT'S "VARIX WAS SUCTIONED, (THE) BAND WAS DEPLOYED AND (IT) SEVERED THE VARIX CAUSING A SIGNIFICANT BLEED." IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT, THEN A COMPETITOR'S DEVICE WAS USED TO STOP THE BLEEDING AND TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY FURTHER COMPLICATIONS OR ILL EFFECTS DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPER VIEW SUPER 7 MND BOSTON SCIENTIFIC CORPORATION M00542250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other