BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3894050 · Received June 25, 2014

    Report

    Report Number
    3005099803-2014-02316
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE LIGATOR HEAD WITH THREE REMAINING BLUE BANDS ON THE HEAD MOVED OUT OF POSITION WITH ONE BAND CAUGHT UNDER THE OTHER. THE FIRST THREE BLUE BANDS AND THE WHITE BAND WERE DEPLOYED AND NOT RETURNED. THE LIGATOR HEAD TEETH DID NOT SHOW ANY DAMAGE AND NO SUTURE WAS ATTACHED TO THE LIGATOR HEAD. THE INTACT SUTURE WAS FOUND TO BE ATTACHED TO THE TRIP WIRE LOOP AND WRAPPED AROUND THE HANDLE BETWEEN THE KNOB AND THE HANDLE BASE. THE TRIP WIRE WAS NOTED TO BE PARTIALLY CAUGHT BETWEEN THE KNOB AND THE HANDLE BASE, AND NOT SECURED IN THE HANDLE ASSEMBLY SLOT WITH THE PROXIMAL LOOP RETRACTED INTO THE HANDLE ASSEMBLY. THERE WAS NO EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED INTO THE HANDLE ASSEMBLY SLOT DURING USE. FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED AND NO ISSUE WAS NOTED. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS PROPERLY SECURED IN THE HANDLE SLOT AS INSTRUCTED IN THE DFU, WHICH IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS, THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF BAND FAILED TO DEPLOY. REPORTED EVENT OF SUTURE BROKE. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE AFTER THE TWO BANDS WERE DEPLOYED RESULTING IN THE FAILURE TO DEPLOY THE THIRD BAND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING 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 DEVICE WAS USED DURING A VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE AFTER THE TWO BANDS WERE DEPLOYED RESULTING IN THE FAILURE TO DEPLOY THE THIRD BAND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371085 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 16884520

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR