BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2855066 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05650
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER: IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE HANDLE ASSEMBLY, TRIPWIRE, SUTURE, AND LIGATOR HEAD WERE RETURNED FOR EVALUATION. THERE WAS RESIDUE PRESENT ON THE DEVICE WHICH IS INDICATIVE OF USE. THE EVALUATION REVEALED THAT THE LIGATOR HEAD RETURNED WITH NO BANDS PRESENT AND THE LIGATOR TEETH UNDAMAGED. THE SUTURE, WHICH RETURNED BROKEN, WAS ATTACHED PROXIMALLY TO THE TRIPWIRE LOOP, WHILE THE DISTAL SECTION WAS CAUGHT ON THE PROXIMAL END OF THE TRIPWIRE. FURTHER ANALYSIS OF THE HANDLE ASSEMBLY REVEALED THAT THE TRIPWIRE WAS CINCHED (SECURED) IN THE HANDLE ASSEMBLY SLOT. ADDITIONALLY, THE PROXIMAL SECTION OF TRIPWIRE WAS FOUND TO BE CURLED. THE CONDITION OF THE RETURNED INCIDENT DEVICE COULD NOT BE EVALUATED WITH RESPECT TO THE REPORTED ISSUE OF ALL BANDS DEPLOYED PREMATURELY. ALTHOUGH THE EVALUATION REVEALED THAT THE LIGATOR HEAD RETURNED WITH NO BANDS PRESENT, THE SPECIFIC CAUSE OF THE ISSUE WAS NOT ABLE TO BE IDENTIFIED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE.

    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 AN ESOPHAGEAL VARICE LIGATION (EVL) PROCEDURE, WITHIN THE MIDDLE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BAND WAS DEPLOYED WITHOUT ISSUE HOWEVER; WHEN AN ATTEMPT TO DEPLOY THE SECOND BAND WAS MADE, ALL THE REMAINING BANDS DEPLOYED OFF THE LIGATOR HEAD AT THE SAME TIME. THE CASE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE 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 AN ESOPHAGEAL VARICE LIGATION (EVL) PROCEDURE, WITHIN THE MIDDLE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BAND WAS DEPLOYED WITHOUT ISSUE HOWEVER; WHEN AN ATTEMPT TO DEPLOY THE SECOND BAND WAS MADE, ALL THE REMAINING BANDS DEPLOYED OFF THE LIGATOR HEAD AT THE SAME TIME. THE CASE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542250

    Patients

    Seq Age Sex Outcome Treatment
    1