BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3201237 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06326
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2013-06214 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE FOR THE BANDING OF ESOPHAGEAL VARICES ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INTERNAL WIRE SNAPPED, AND NO BANDS WERE ABLE TO BE RELEASED. NO VISIBLE DAMAGE WAS NOTED PRIOR TO THE PROCEDURE. A SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED, AND TWO BANDS MAY HAVE BROKEN AND MISFIRED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SECOND DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301664 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 15993039

    Patients

    Seq Age Sex Outcome Treatment
    1