BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2062775 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01328
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE HANDLE WAS UNLOCKED; HOWEVER, THE CLIP ASSEMBLY WAS DETACHED FROM THE DELIVERY SYSTEM. THE CLIP ASSEMBLY AND BUSHING WERE SEVERELY DAMAGED. ADDITIONALLY, THE MINI-SHEATH APPEARED BUCKLED AS A RESULT OF THE DUODENOSCOPE ELEVATOR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. SINCE THE CLIP ASSEMBLY WAS DETACHED FROM THE DELIVERY SYSTEM, THE REPORTED EVENT OF "FAILURE TO RELEASE FROM CATHETER AND WON'T OPEN/CLOSE" COULD NOT BE CONFIRMED. BASED ON THE OBSERVED DAMAGE TO THE MINI-SHEATH AND CLIP ASSEMBLY, THE DEVICE WAS MOST LIKELY ADVANCED OVER THE RAISED DUODENOSCOPE ELEVATOR; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS USE/USER ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4):ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE RESOLUTION II CLIP WOULD NOT OPEN AND CLOSE PROPERLY AND IT ALSO WOULD NOT DETACH FROM THE CATHETER. THE PHYSICIAN REPOSITIONED THE RESOLUTION II CLIP AND STRAIGHTENED IT OUT BECAUSE IT HAD BENT; HOWEVER THE SAME ISSUE OCCURRED. THE CLIP WAS REMOVED FROM THE PATIENT AND A BSC TOME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE RESOLUTION II CLIP WOULD NOT OPEN AND CLOSE PROPERLY AND IT ALSO WOULD NOT DETACH FROM THE CATHETER. THE PHYSICIAN REPOSITIONED THE RESOLUTION II CLIP AND STRAIGHTENED IT OUT BECAUSE IT HAD BENT; HOWEVER THE SAME ISSUE OCCURRED. THE CLIP WAS REMOVED FROM THE PATIENT AND A BSC TOME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION II CLIP LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522512 1ML1020201

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR