BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2760807 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04358
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED RESIDUE WAS PRESENT ON THE DEVICE INDICATING USE. THE LIGATOR ASSEMBLY FOUND THREE BLUE AND ONE WHITE BAND REMAINING ON THE LIGATOR HEAD. THE BANDS ON THE LIGATOR HEAD WERE NOT ROLLED OUT OF POSITION AND THE TEETH OF THE LIGATOR HEAD WERE NOT DAMAGED. THE SUTURE LOOP WAS ATTACHED TO THE WIRE LOOP OF THE TRIP WIRE HOWEVER; THE SUTURE WAS FOUND TO BE BROKEN; MOST LIKELY FROM REMOVAL FROM SCOPE. AN EXAMINATION OF THE HANDLE ASSEMBLY FOUND THE TRIP WIRE TO BE CINCHED IN THE HANDLE SLOT. ADDITIONALLY, THE PROXIMAL END OF THE TRIP WIRE PRESENTED COILING AS IF IT HAD BEEN TWISTED AROUND THE SPOOL AND WAS COILED AROUND THE SPOOL ONLY 1½ REVOLUTIONS. 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 THREE BLUE BANDS AND ONE WHITE BAND REMAINED ON THE LIGATOR HEAD IN THE PROPER POSITION AND THERE WAS NO DAMAGE TO THE TEETH ON THE LIGATOR HEAD. ADDITIONALLY IT APPEARS THE TRIP WIRE WAS NOT CINCHED PROPERLY DURING USE BUT WOUND AROUND THE HANDLE INSTEAD AND CINCHED AFTER THE PROCEDURE WAS IN-PROCESS. THE FAILURE OCCURRED DURING THE ATTEMPT TO DEPLOY THE 4TH BAND. IF THE TRIPWIRE HAD BEEN SECURELY CINCHED, THE TRIPWIRE SHOULD HAVE BEEN COILED AROUND THE SPOOL 2 FULL REVOLUTIONS. 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.' THE FAILURE TO CINCH THE TRIPWIRE COULD ULTIMATELY IMPACT THE DEPLOYMENT ACTIVITY OF THE BANDS, WHICH WOULD CREATE SLACK IN THE WIRE, AND NEGATIVELY IMPACT THE BAND DEPLOYMENT ACTIVITIES. THE BANDS FAILURE TO DEPLOY WAS MOST LIKELY 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A SPEEDBAND WAS USED A DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, AFTER THE LIGATION BAND WAS FIRED THREE TIMES WITH THE DEVICE SUCCESSFULLY, IT WAS ATTEMPTED TO FIRE A FOURTH TIME; HOWEVER IT WAS DIFFICULT TO FIRE AND TRIPWIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A SPEEDBAND WAS USED A DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, AFTER THE LIGATION BAND WAS FIRED THREE TIMES WITH THE DEVICE SUCCESSFULLY, IT WAS ATTEMPTED TO FIRE A FOURTH TIME; HOWEVER IT WAS DIFFICULT TO FIRE AND TRIPWIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 15027734

    Patients

    Seq Age Sex Outcome Treatment
    1