BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3910235 · Received July 2, 2014

    Report

    Report Number
    3005099803-2014-02418
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE SUTURE INTACT AND REMOVED FROM THE LIGATOR HEAD AND STILL ATTACHED TO THE TRIP WIRE LOOP. FOUR BLUE BANDS REMAINED ON THE LIGATOR HEAD AND ALL WERE MOVED OUT OF POSITION. THE FIRST TWO BLUE BANDS AND THE WHITE SIXTH BAND WERE DEPLOYED AND NOT RETURNED. THE LIGATOR HEAD TEETH WERE NOTED TO BE DAMAGED. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. THERE WAS NO EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED INTO THE HANDLE ASSEMBLY SLOT 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 TO THE HANDLE. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS SECURED IN THE HANDLE ASSEMBLY SLOT, AS INSTRUCTED IN THE DFU, WHICH IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF BANDS FAILED TO DEPLOY. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS IS ONE OF TWO REPORTS RELATED TO THE SAME EVENT (MFR. REPORT #, 3005099803-2014-02418 AND MFR. REPORT # 3005099803-2014-02427). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE IN THE LOWER ESOPHAGUS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RELEASE THE BAND ON THE FIRST SPEEDBAND DEVICE (THE SUBJECT OF MFR. REPORT #, 3005099803-2014-02418); HOWEVER, THE BAND FAILED TO DEPLOY. A SECOND SPEEDBAND DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2014-02427) WAS OPENED, BUT OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED THAT THE SUTURE OF THE DEVICE TIP WAS DAMAGED AND THE PHYSICIAN DID NOT ATTEMPT TO DEPLOY THE BAND. ANOTHER SPEEDBAND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS IS ONE OF TWO REPORTS RELATED TO THE SAME EVENT (MFR. REPORT #, 3005099803-2014-02418 AND MFR. REPORT # 3005099803-2014-02427). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE IN THE LOWER ESOPHAGUS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RELEASE THE BAND ON THE FIRST SPEEDBAND DEVICE (THE SUBJECT OF MFR. REPORT #, 3005099803-2014-02418); HOWEVER, THE BAND FAILED TO DEPLOY. A SECOND SPEEDBAND DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2014-02427) WAS OPENED, BUT OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED THAT THE SUTURE OF THE DEVICE TIP WAS DAMAGED AND THE PHYSICIAN DID NOT ATTEMPT TO DEPLOY THE BAND. ANOTHER SPEEDBAND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386726 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16583339

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR