BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2143284 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02211
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS IN A CLOSED POSITION, BUT NOT LOCKED. ADDITIONALLY, THE CLIP ASSEMBLY WAS MASHED INTO/ONTO THE BUSHING AND THE CAPSULE WAS JAMMED INTO THE BUSHING. BOTH THE CAPSULE AND BUSHING WERE SEVERELY DAMAGED. ANALYSIS OF THE HANDLE FOUND THAT THE HANDLE LOCKS HAD BEEN OVERCOME DUE TO EXCESSIVE FORCE. FUNCTIONALLY, THE CLIP WAS NOT ABLE TO BE OPENED. THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE OBSERVED DEVICE DAMAGE WOULD HAVE PREVENTED DEPLOYMENT. BASED ON THE EVALUATION, THE DAMAGE LIKELY OCCURRED DUE TO THE DEVICE HAVING BEEN ADVANCED OVER THE RAISED DUODENOSCOPE ELEVATOR; THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER ERROR.

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. 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 DEVICE WAS USED TO TREAT A POST-SPHINCTEROTOMY BLEED AT THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE CLIP WAS DIFFICULT TO DEPLOY. THE PHYSICIAN EVENTUALLY WAS ABLE TO SEPARATE THE CLIP FROM THE DELIVERY SYSTEM AND ONTO THE TISSUE; HOWEVER, THE CLIP THEN FELL OFF THE TISSUE INTO THE PATIENT. THE CLIP WAS NOT RETRIEVED AND THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT THE BLEEDING SUBSIDED ON ITS OWN AND NO FURTHER TREATMENT WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED TO TREAT A POST-SPHINCTEROTOMY BLEED AT THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE CLIP WAS DIFFICULT TO DEPLOY. THE PHYSICIAN EVENTUALLY WAS ABLE TO SEPARATE THE CLIP FROM THE DELIVERY SYSTEM AND ONTO THE TISSUE; HOWEVER, THE CLIP THEN FELL OFF THE TISSUE INTO THE PATIENT. THE CLIP WAS NOT RETRIEVED AND THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT THE BLEEDING SUBSIDED ON ITS OWN AND NO FURTHER TREATMENT WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION II CLIP LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522510

    Patients

    Seq Age Sex Outcome Treatment
    1