BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4111284 · Received September 23, 2014

    Report

    Report Number
    3005099803-2014-03187
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED PRESENCE OF RESIDUE INDICATING USE/HANDLING. THE SUTURE WAS BROKEN WITH PORTIONS STILL ATTACHED TO THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THE TRIP WIRE WAS SECURED IN THE HANDLE ASSEMBLY SLOT. THERE WAS NO ISSUE NOTED WITH THE EXTENSION TUBE, ADAPTOR RING AND THE LIGATOR HEAD TEETH. FOUR BANDS REMAINED ON THE LIGATOR HEAD AND WERE MOVED OUT OF POSITION. TWO BANDS WERE DEPLOYED AND ONE OF THE DEPLOYED BANDS WAS BROKEN. FUNCTIONAL EVALUATION WAS PERFORMED BY TURNING THE HANDLE AND AN AUDIBLE CLICK WAS HEARD. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BAND FAILED TO DEPLOY WAS CONFIRMED. HOWEVER, GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. 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 CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING A VARICEAL BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TESTED THE DEVICE BY DEPLOYING THE FIRST BAND; HOWEVER, THE BANDS GOT TWISTED UP AND NO MORE BANDS WILL DEPLOY. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING A VARICEAL BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TESTED THE DEVICE BY DEPLOYING THE FIRST BAND; HOWEVER, THE BANDS GOT TWISTED UP AND NO MORE BANDS WILL DEPLOY. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590230 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 17050722

    Patients

    Seq Age Sex Outcome Treatment
    1