BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3923575 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02476
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THERE WAS NO ISSUE NOTED WITH THE IRRIGATION TUBE. THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED TO BOTH THE LIGATOR HEAD AND THE TRIP WIRE LOOP. ALL SEVEN BANDS WERE PRESENT ON THE LIGATOR HEAD; WITH THE FIRST FOUR BLUE BANDS MOVED OUT OF POSITION AND DAMAGED. THE TRIP WIRE WAS NOTED WOUND TWO REVOLUTION AROUND THE SPOOL OF THE HANDLE ASSEMBLY. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT BUT PRESENTED EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED PRIOR TO RECEIPT. THE LIGATOR HEAD WAS RETURNED WITH DAMAGED TEETH. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED AND NO ISSUE WAS NOTED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BANDS FAILED TO DEPLOY WAS CONFIRMED. 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 REVEALED THAT NO OTHER 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 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO TURN THE HANDLE WITHOUT DIFFICULTY. HE WAS ABLE TO SUCCESSFULLY DEPLOY THE FIRST TWO LIGATION BANDS; HOWEVER, THE REST OF THE BANDS FAILED TO 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. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    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 AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO TURN THE HANDLE WITHOUT DIFFICULTY. HE WAS ABLE TO SUCCESSFULLY DEPLOY THE FIRST TWO LIGATION BANDS; HOWEVER, THE REST OF THE BANDS FAILED TO 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. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400378 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16399693

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR