BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203

    MDR report key: 2130068 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02136
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SUTURE ATTACHED TO THE LIGATOR HEAD APPEARED TO HAVE BEEN BROKEN AND THE OTHER END OF THE SUTURE, WHICH IS ATTACHED TO THE TRIP WIRE, ALSO APPEARED TO HAVE BEEN BROKEN. THE TRIP WIRE WAS FOUND TO BE KINKED. FURTHER ANALYSIS OF THE LIGATOR HEAD FOUND THAT IT RETURNED WITH SIX BANDS ATTACHED. THE BANDS HAVE BEEN MOVED FROM THEIR ORIGINAL POSITION WHICH IS INDICATIVE OF A DEPLOYMENT ATTEMPT. ADDITIONALLY, THE LIGATOR HEAD TEETH WERE FOUND TO BE DAMAGED. FUNCTIONALLY, THE HANDLE KNOB WAS ABLE TO BE TURNED WITHOUT ISSUE AND CLICKED APPROPRIATELY AFTER EACH 180 DEGREE ROTATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS NOT ABLE TO BE USED. THE EVALUATION FOUND THAT THE LIGATOR HEAD TEETH WERE DAMAGED AND THE SUTURE WAS BROKEN. BASED ON THE EVALUATION FINDINGS AND EVENT DETAILS, THIS DAMAGE LIKELY OCCURRED WHILE PREPARING THE DEVICE FOR USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. 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.

    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 AN ESOPHAGEAL VARICES BANDING PROCEDURE, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS REPORTED THAT "THE LIGATING UNIT COULD NOT BE MOVED AND THIS DEVICE COULD NOT BE USED." 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. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE EVENT AMBIGUITY, THIS IS BEING REPORTED AS FAILED TO DEPLOY. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 AN ESOPHAGEAL VARICES BANDING PROCEDURE, PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS REPORTED THAT "THE LIGATING UNIT COULD NOT BE MOVED AND THIS DEVICE COULD NOT BE USED." 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. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE EVENT AMBIGUITY, THIS IS BEING REPORTED AS FAILED TO DEPLOY. 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 4203 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542250 13844163

    Patients

    Seq Age Sex Outcome Treatment
    1