BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2780405 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04749
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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 1 BLUE BAND WAS PRESENT ON THE LIGATOR HEAD AND WAS ROLLED OUT OF POSITION. THE LIGATOR TEETH WERE NOT DAMAGED. ADDITIONALLY, THE SUTURE LOOP WAS INTACT AND ATTACHED TO THE WIRE LOOP OF THE TRIP WIRE HOWEVER; THE SUTURE HAD BEEN REMOVED FROM THE LIGATOR HEAD. FURTHER ANALYSIS FOUND THE TRIP WIRE TO NOT BE CINCHED IN THE HANDLE ASSEMBLY SLOT OF THE HANDLE HOWEVER; THE HANDLE SLOT DID PRESENT SLIGHT EVIDENCE THAT THE TRIP WIRE HAD BEEN PREVIOUSLY SECURED. THE TRIPWIRE WAS LOOSELY WRAPPED AROUND THE SPOOL WITH THE PROXIMAL END OF THE TRIP WIRE COILED AND APPEARS TO HAVE BEEN WRAPPED AROUND THE SPOOL PRIOR TO THE TRIP WIRE BEING SECURED IN THE SLOT. 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 ONE BAND WAS PRESENT ON THE LIGATOR HEAD AND THE SUTURE HAD BEEN REMOVED. IN ADDITION, THE LIGATOR TEETH PRESENTED NO DAMAGED. ADDITIONALLY, THE TRIP WIRE WAS LOOSELY WRAPPED AROUND THE HANDLE SPOOL AND THE PROXIMAL END OF THE TRIP WIRE PRESENTED COILING AS IF IT HAD BEEN TWISTED AROUND THE SPOOL. ALSO, THE TRIP WIRE WAS NOT SECURED IN THE HANDLE SLOT ALTHOUGH, IT APPEARS THE TRIP WIRE WAS SECURED AT SOME TIME PRIOR TO RECEIPT. FAILURE TO TIGHTEN THE TRIP WIRE COULD ULTIMATELY IMPACT THE DEPLOYMENT ACTIVITY OF THE BANDS. IF SLACK WAS PRESENT IN THE TRIPWIRE DURING THE PROCEDURE IT COULD CAUSE THE THREAD TO MOVE OVER THE LIGATOR TEETH WITHOUT DEPLOYING THE BANDS PROPERLY. BASED ON THE EVALUATION OF THE DEVICE AND EVALUATION OF RETURNED DEVICES WITH SIMILAR ISSUES, IT IS MOST LIKELY THAT ANATOMICAL / PROCEDURAL / OPERATIONAL FACTORS WERE ENCOUNTERED DURING THE PROCEDURE THAT IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-04748 AND 3005099803-2012-04749 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICES WERE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING IN THE DISTAL ESOPHAGUS PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS ROLLED OUT OF POSITION, BUT FAILED TO DEPLOY FROM THE SPEEDBAND (MR # 3005099803-2012-04748) DEVICE. A SECOND SPEEDBAND (MR # 3005099803-2012-04749) DEVICE WAS THEN USED; HOWEVER, DURING DEPLOYMENT, TWO BANDS WERE RELEASED. THE PHYSICIAN COMPLETED THE PROCEDURE USING TWO BANDS FROM THE SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-04748 AND 3005099803-2012-04749 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICES WERE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING IN THE DISTAL ESOPHAGUS PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS ROLLED OUT OF POSITION, BUT FAILED TO DEPLOY FROM THE SPEEDBAND (MR # 3005099803-2012-04748) DEVICE. A SECOND SPEEDBAND (MR # 3005099803-2012-04749) DEVICE WAS THEN USED; HOWEVER, DURING DEPLOYMENT, TWO BANDS WERE RELEASED. THE PHYSICIAN COMPLETED THE PROCEDURE USING TWO BANDS FROM THE SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 0015135599

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR