BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3061430 · Received April 16, 2013

    Report

    Report Number
    3005099803-2013-02714
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS CONNECTED TO THE BUSHING. THE PRONGS COULD NOT BE OPENED BECAUSE THEY WERE LOCKED INTO THE CAPSULE. THE CLIP ASSEMBLY COULD BE DEPLOYED AND ONE CLICK WAS HEARD. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN AND UNAVAILABLE; HOWEVER THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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 CLIP DEVICE WAS USE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. THE CLIP WAS UNABLE TO BE REOPENED AND HAD TO BE PULLED OFF THE TISSUE. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. THE CLIP WAS UNABLE TO BE REOPENED AND HAD TO BE PULLED OFF THE TISSUE. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162470 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000425C3

    Patients

    Seq Age Sex Outcome Treatment
    1