BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2062770 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01321
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE HANDLE WAS LOCKED AND THE CLIP ASSEMBLY WAS NOT RETURNED. A KINK WAS VISIBLE IN THE CONTROL WIRE NEAR THE HANDLE. ADDITIONALLY, THE BUSHING ARM WAS DAMAGED WHICH CAUSED THE MINI-SHEATH TO BUCKLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. THE REPORTED ISSUE OF FAILURE TO RELEASE WAS NOT ABLE TO BE CONFIRMED AS THE CLIP ASSEMBLY WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE ISSUE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    COMPONENT (B)(6) RELATES TO DEVICE (B)(6) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. 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 POST-POLYPECTOMY ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER A POLYPECTOMY, A RESOLUTION II CLIP WAS SUCCESSFULLY ATTACHED TO TISSUE; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE CLIP FROM THE CATHETER, A "BIG CRACKLE" WAS HEARD INSIDE THE HANDLE. THE CLIP DID NOT RELEASE FROM THE DELIVERY CATHETER AND WAS FIXED ON TO THE MUCOSA. THE DUODENOSCOPE WAS STRAIGHTENED VERTICALLY AND THE CLIP WAS BLOCKED AGAIN THE MUCOSA. THE PHYSICIAN GAVE A STRONG PULL ON THE DELIVERY CATHETER AND THE CLIP FINALLY RELEASED. NO ADDITIONAL BLEEDING OR TISSUE DAMAGE OCCURRED AS A RESULT OF THIS EVENT. THE CLIP REMAINED ATTACHED TO THE MUCOSA AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE "OKAY" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP WAS USED POST-POLYPECTOMY ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER A POLYPECTOMY, A RESOLUTION II CLIP WAS SUCCESSFULLY ATTACHED TO TISSUE; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE CLIP FROM THE CATHETER, A "BIG CRACKLE" WAS HEARD INSIDE THE HANDLE. THE CLIP DID NOT RELEASE FROM THE DELIVERY CATHETER AND WAS FIXED ON TO THE MUCOSA. THE DUODENOSCOPE WAS STRAIGHTENED VERTICALLY AND THE CLIP WAS BLOCKED AGAIN THE MUCOSA. THE PHYSICIAN GAVE A STRONG PULL ON THE DELIVERY CATHETER AND THE CLIP FINALLY RELEASED. NO ADDITIONAL BLEEDING OR TISSUE DAMAGE OCCURRED AS A RESULT OF THIS EVENT. THE CLIP REMAINED ATTACHED TO THE MUCOSA AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE "OKAY" 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 60 YR