BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1911801 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-05004
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS (B)(6) 2010. PATIENT CONDITION - STABLE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2010 WHICH CLARIFIES THE EVENT AND CORRECTS SOME OF THE INFORMATION FROM THE INITIAL REPORT: THIS MANUFACTURER REPORT (MFR) AND MANUFACTURER REPORT 3005099803-2010-05005 ADDRESS THE SAME PATIENT. AN ESOPHAGEAL VARIX BANDING PROCEDURE USING A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS PERFORMED ON (B)(6) 2010 BY DR. (B)(6). THERE WAS ADEQUATE PREPARATION AND THE DEVICE WAS IN PLACE, HOWEVER THE BAND FAILED TO DEPLOY (THIS EVENT IS ADDRESSED BY THIS REPORT MFR 3005099803-2010-05004). THE PROCEDURE WAS ABORTED. A SECOND ESOPHAGEAL VARIX BANDING PROCEDURE WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS ATTEMPTED BY DR. (B)(6) ON (B)(6) 2010. THERE WAS ADEQUATE PREPARATION AND THE DEVICE WAS IN PLACE; HOWEVER THE BAND FAILED TO DEPLOY. THE PROCEDURE WAS ABORTED AND IT IS UNKNOWN HOW THE PATIENT WAS ULTIMATELY TREATED (ALTHOUGH THE PATIENT'S CONDITION HAS BEEN REPORTED AS "STABLE").

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY DREW UP THE VARICE AND ATTEMPTED TO DEPLOY A BAND HOWEVER THE BAND DID NOT DEPLOY. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 13656647

    Patients

    Seq Age Sex Outcome Treatment
    1