BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2903530 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00100
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 31, 2012
    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 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 THREE BANDS PRESENT; TWO BLUE AND ONE WHITE. ALL BANDS WERE ROLLED OUT OF POSITION. IN ADDITION, THE LIGATOR TEETH WERE VISIBLY DAMAGED. THE SUTURE RETURNED BROKEN WITHOUT THE PROXIMAL SECTION. FURTHER ANALYSIS OF THE HANDLE ASSEMBLY REVEALED THAT THE TRIPWIRE WAS NOT CINCHED (SECURED) IN THE HANDLE ASSEMBLY SLOT. HOWEVER, THE HANDLE ASSEMBLY SLOT PRESENTED WITH SLIGHT EVIDENCE THAT THE TRIPWIRE HAD BEEN SECURED AT SOME POINT PRIOR TO RECEIPT. FURTHERMORE, THE PROXIMAL SECTION OF THE TRIPWIRE WAS FOUND TO BE KINKED AND CURLED. FUNCTIONALLY, THE HANDLE ASSEMBLY KNOB WAS ABLE TO BE TURNED WITH AN AUDIBLE CLICK OCCURRING ON EVERY ROTATION OF 180 DEGREES. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE REPORTED EVENT OF BAND DEPLOYMENT ISSUES. THE EVALUATION REVEALED THAT THE TEETH OF THE LIGATOR HEAD WERE DAMAGED, AND THE THREE BANDS THAT WERE PRESENT HAD ROLLED OUT OF POSITION. ADDITIONALLY, THE SUTURE WAS FOUND TO BE BROKEN. THIS DAMAGE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AND ADVERSELY IMPACTED BAND DEPLOYMENT ACTIVITIES. 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 NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 DEVICE WAS USED FOR A PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND WAS UNABLE TO BE DEPLOYED FROM THE SPEEDBAND DEVICE. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. PRIOR TO USE, NO DAMAGE WAS VISIBLE TO THE DEVICE OR ITS PACKAGING. ADDITIONALLY, THE SCOPE WAS NOT IN A RETROFLEX POSITION AND A PROCEDURAL DELAY OF APPROXIMATELY 1 TO 5 MINUTES OCCURRED. NO PATIENT COMPLICATIONS RESULTED FROM 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 DEVICE WAS USED FOR A PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND WAS UNABLE TO BE DEPLOYED FROM THE SPEEDBAND DEVICE. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. PRIOR TO USE, NO DAMAGE WAS VISIBLE TO THE DEVICE OR ITS PACKAGING. ADDITIONALLY, THE SCOPE WAS NOT IN A RETROFLEX POSITION AND A PROCEDURAL DELAY OF APPROXIMATELY 1 TO 5 MINUTES OCCURRED. NO PATIENT COMPLICATIONS RESULTED FROM 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
    11584 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 15122260

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR