BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 2163646 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02372
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SUTURE ON LIGATOR HEAD WAS BROKEN AND HAD A TOTAL OF THREE KNOTS PRESENT IN THE RECEIVED LENGTH. THE SUTURE IS DAMAGED APPROXIMATELY 2" FROM THE DISTAL END. IN ADDITION, THERE WAS RESIDUE FOUND ON THE LIGATOR HEAD. THERE WERE FIVE BLUE BANDS PRESENT ON THE LIGATOR AND ONE WHITE BAND. THREE OF THE BLUE BANDS HAVE BEEN DISPLACED FROM THEIR ORIGINAL POSITION AS SHIPPED. THE TEETH ON THE LIGATOR HEAD ARE DAMAGED. SINCE THE HANDLE WAS NOT RETURNED A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED ON THE DEVICE. A VISUAL EVALUATION (TEETH DAMAGE AND BROKEN SUTURE) WAS SUFFICIENT TO DETERMINE THAT THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BANDS WOULD NOT DEPLOY FROM THE LIGATOR HEAD. THE BROKEN SUTURE MAY HAVE BEEN IMPACTED BECAUSE OF POTENTIAL SLACK BUILT UP IN THE WIRE, WHICH CAN INCREASE THE FORCE ON THE THREAD AND CAUSING FURTHER TOOTH DAMAGE, AND/OR CAUSING THE THREAD TO BREAK AS OBSERVED FROM THIS COMPLAINT. THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEGUN AS OF YET. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED FOR A BANDING PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY MADE AN ATTEMPT TO DEPLOY THE BANDS HOWEVER, THE BANDS WOULD NOT DEPLOY. 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 FOR A BANDING PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY MADE AN ATTEMPT TO DEPLOY THE BANDS HOWEVER, THE BANDS WOULD NOT DEPLOY. 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, MODELS 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 14277306

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR