BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3022589 · Received March 27, 2013

    Report

    Report Number
    3005099803-2013-02226
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVALUATION FINDINGS OF CLIP FAILED TO RELEASE FROM CATHETER. A VISUAL EXAMINATION FOUND THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NOT BE OPENED OR CLOSED. THE PRONGS WERE LOCKED INTO THE CAPSULE. IN ADDITION, THE OVER SHEATH WAS NOT RETURNED. THE EVALUATION FOUND THAT THE CLIP COULD NOT BE OPENED OR CLOSED BECAUSE THE CLIP ASSEMBLY WAS MASHED INTO THE BUSHING. FUNCTIONAL EVALUATION ALSO REVEALED THAT THE DEVICE WOULD NOT DEPLOY. THE ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. 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 THAT A RESOLUTION CLIP DEVICE WAS TO BE USED DURING A COLONOSCOPY PROCEDURE, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE OF THE PATIENT, THE DEVICE WAS TESTED HOWEVER; THE CLIP COULD NOT OPEN OR CLOSE. THE DEVICE WAS REMOVED FROM SERVICE AND THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. NO ADDITIONAL DAMAGE OR ISSUES WERE REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CLIP WAS DAMAGED AND FUNCTIONALLY WOULD NOT RELEASE FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125973 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000397C3

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR