BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2760874 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04338
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. 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 FOUND THAT THE HANDLE ASSEMBLY, TRIPWIRE, SUTURE, AND LIGATOR HEAD WERE RETURNED FOR EVALUATION. THERE WAS RESIDUE PRESENT ON THE DEVICE WHICH IS INDICATIVE OF USE. THE EVALUATION REVEALED THAT FOUR BANDS REMAINED ON THE LIGATOR HEAD; 3 BLUE AND 1 WHITE. HOWEVER, ONE OF THE BLUE BANDS HAD ROLLED OUT OF POSITION. NO DAMAGE WAS VISIBLE TO THE LIGATOR TEETH. ADDITIONALLY, THE SUTURE, WHICH RETURNED ATTACHED TO THE TRIPWIRE LOOP, WAS SEPARATED FROM THE LIGATOR HEAD, BUT REMAINED INTACT. FURTHER ANALYSIS CONFIRMED THE TRIPWIRE TO BE PROPERLY CINCHED (SECURED) IN THE HANDLE ASSEMBLY SLOT. FUNCTIONALLY, THE HANDLE SPOOL WAS ABLE TO BE ROTATED AND CLICKED APPROPRIATELY WITH EVERY 180 DEGREES OF ROTATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE RETURNED DEVICE VISUALLY REFLECTS THE REPORTED ISSUE. THE EVALUATION REVEALED THAT FOUR BANDS REMAINED ON THE RETURNED LIGATOR HEAD. ALTHOUGH THE TRIPWIRE RETURNED PROPERLY CINCHED (SECURED) IN THE HANDLE SLOT, THE POSSIBILITY REMAINS THAT IT WAS NOT TENSIONED APPROPRIATELY. THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DIRECTIONS FOR USE (DFU) NOTES WITHIN THE INITIAL SETUP SECTION ¿TO PULL GENTLY ON TRIP WIRE TO TAKE UP REST OF SLACK. STOP APPLYING TENSION WHEN RESISTANCE OCCURS.¿ THE DFU THEN INSTRUCTS THE USER TO ¿SECURE TRIP WIRE IN SLOT ON HANDLE UNIT.¿ FAILURE TO PROPERLY TENSION THE TRIPWIRE COULD POTENTIALLY IMPACT BAND DEPLOYMENT BY ALLOWING SLACK TO BUILD UP, WHICH ULTIMATELY WOULD HAVE A NEGATIVE IMPACT ON BAND DEPLOYMENT ACTIVITIES. THIS EVENT LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYMENT WAS ATTEMPTED, THE SPEEDBAND DEVICE (MR # 3005099803-2012-04338) WAS ONLY ABLE TO DEPLOY THREE BANDS OUT OF THE SEVEN. ANOTHER SPEEDBAND DEVICE (MR # 3005099803-2012-04340) WAS THEN USED, HOWEVER; NONE OF THE BANDS WOULD DEPLOY. THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYMENT WAS ATTEMPTED, THE SPEEDBAND DEVICE (MR # 3005099803-2012-04338) WAS ONLY ABLE TO DEPLOY THREE BANDS OUT OF THE SEVEN. ANOTHER SPEEDBAND DEVICE (MR # 3005099803-2012-04340) WAS THEN USED, HOWEVER; NONE OF THE BANDS WOULD DEPLOY. THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 0015396738

    Patients

    Seq Age Sex Outcome Treatment
    1