BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4528537 · Received February 19, 2015

    Report

    Report Number
    3005099803-2015-00306
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    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

    A SPEEDBAND DEVICE WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THERE WAS NO ISSUE WITH THE EXTENSION TUBE. THE SUTURE WAS INTACT AND ATTACHED TO THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THE TRIP WIRE WAS CUT AT APPROXIMATELY 80 CM FROM THE DISTAL END. FIVE BANDS REMAINED ON THE LIGATOR HEAD, WITH FOUR OF THE BANDS MOVED OUT OF POSITION. THE LIGATOR TEETH WERE BADLY DAMAGED, WITH TWO OF ITS TEETH MISSING. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. THE HANDLE ASSEMBLY SLOT AND TRIP WIRE DID NOT PRESENT EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB 180º AND AN AUDIBLE CLICK WAS HEARD, NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT COULD NOT BE FUNCTIONALLY VERIFIED THAT THE BANDS FAILED TO DEPLOY DURING THE PROCEDURE. HOWEVER, FINDINGS FROM THE VISUAL EVALUATION INDICATE THAT THE DEVICE MOST LIKELY FAILED TO DEPLOY THE BANDS DURING THE PROCEDURE. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS CINCHED IN THE HANDLE SLOT DURING SET UP PER THE DIRECTIONS FOR USE (DFU). FAILING TO PROPERLY SET UP THE DEVICE WOULD IMPACT THE DEPLOYMENT ACTIVITY OF THE BANDS. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS COMPLAINT IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LIGATION BANDS FAILED TO DEPLOY INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER A SPEEDBAND SUPERVIEW SUPER 7 DEVICE. 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.

    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 ESOPHAGEAL VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LIGATION BANDS FAILED TO DEPLOY INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER A SPEEDBAND SUPERVIEW SUPER 7 DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118173 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16837997

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR