BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1894343 · Received November 9, 2010

    Report

    Report Number
    3005099803-2010-04609
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A TOTAL OF 5 BANDS INTACT ON THE LIGATOR HEAD WHICH WERE UN-DEPLOYED AND DISORIENTED AND 1 BAND WAS FOUND BROKEN AND SEPARATED FROM THE LIGATOR HEAD. THE TEETH ON THE LIGATOR HEAD WERE FOUND TO BE DAMAGED LIKELY DUE TO THE USAGE OF THE DEVICE. THE TRIP WIRE ON THE HANDLE ASSEMBLY WAS FOUND TO BE CINCHED INTO THE HANDLE SLOT BUT WAS BROKEN AT THE PROXIMAL END. THE TRIP WIRE WAS ALSO WOUND AROUND THE DRUM, INDICATING THE HANDLE HAD BEEN TURNED TO DEPLOY THE BANDS. THE DEPLOYMENT THREAD WAS FOUND SEPARATED FROM THE LIGATOR HEAD BUT WAS NOT BROKEN AND REMAINED ATTACHED TO THE DISTAL END OF THE TRIP WIRE. A FUNCTIONAL CHECK OF THE HANDLE FOUND THAT THE HANDLE KNOB WAS ABLE TO TURN TO TAKE UP SLACKS AND THERE WAS AN AUDIBLE CLICK HEARD AT EACH COMPLETE TURN. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT, AS EVIDENT BY THE TOOTH DAMAGE ON THE LIGATOR HEAD. IT IS LIKELY THAT ANATOMICAL/PROCEDURAL/OPERATIONAL FACTORS IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS AND CAUSED THE TEETH ON THE LIGATOR HEAD TO INADVERTENTLY DAMAGE DURING USE. THIS CAN IN TURN CAUSE THE BANDS TO STACK UP ON THE LIGATOR HEAD AND HINDER THE DEPLOYMENT ACTIVITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, IT HAS NOT BEEN EVALUATED 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) VARICEAL BANDING PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY AND THE HANDLE LOCKED UP. THE CASE WAS COMPLETED WITH A SECOND 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 FINE.

    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 ESOPHAGOGASTRODUODENOSCOPY (EGD) VARICEAL BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY AND THE HANDLE LOCKED UP. THE CASE WAS COMPLETED WITH A SECOND 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 FINE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR