BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 10662573 · Received October 12, 2020

    Report

    Report Number
    3005099803-2020-04538
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 16, 2020
    Report Date
    December 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE 1069 CAPTURES THE REPORTABLE ISSUE OF SUTURE DID NOT KNOT. BLOCK H10: INVESTIGATION RESULTS THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE TRIP WIRE PARTIALLY ROLLED IN THE HANDLE ASSEMBLY AND THE TRIP WIRE WAS KINKED. A CRIMP WAS PRESENT ON THE TRIPWIRE WHILE THE SUTURE LOOP WAS MISSING. DIMENSIONAL EXAMINATION WAS PERFORMED ON THE REMAINING SUTURE SECTION, AND IT WAS FOUND THAT THE MEASUREMENT WAS OUT OF SPECIFICATION, CONFIRMING THE SUTURE LOOP WAS MISSING. THE LIGATOR HEAD WAS WRAPPED IN ITS ORIGINAL PLASTIC, AND THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED. A FUNCTIONAL EVALUATION WAS PERFORMED BY ROTATING THE HANDLE KNOB 180 DEGREES, AN AUDIBLE CLICK WAS HEARD AND INDENTS WERE FELT. NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. THIS FAILURE IS LIKELY DUE TO PROBLEMS TRACED TO MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING DEFICIENCY. AN INVESTIGATION IS IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABELING, AS THE REPORTED ANATOMY LOCATION WAS "GASTRIC VENOUS" WHICH IS OUTSIDE THE INDICATION FOR USE. NOT USING THE DEVICE IN THE PROPER ANATOMICAL LOCATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE. BLOCK H11: CORRECTION: BLOCK B5 (ANATOMY LOCATION).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED IN THE FUNDUS OF STOMACH ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE SUTURE DID NOT KNOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. CORRECTION IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE GASTRIC VENOUS.

    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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEED BAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED IN THE FUNDUS OF STOMACH ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE SUTURE DID NOT KNOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127064 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0025544792 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR