BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3011045 · Received March 19, 2013

    Report

    Report Number
    3005099803-2013-01512
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE PRELIMINARY EVALUATION FINDING OF OVERSHEATH TORN. : A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH THE CLIP ASSEMBLY DETACHED FROM THE BUSHING, BUT STILL ATTACHED TO THE CONTROL WIRE VIA THE TENSION BREAKER AND YOKE. FUNCTIONALLY, THE CLIP ASSEMBLY WAS ABLE TO BE ADVANCED SMOOTHLY; HOWEVER, THE PRONGS WERE IN THE OPEN POSITION. WHEN ACTUATED, THE CLIP ASSEMBLY WAS ABLE TO BE DEPLOYED WITH TWO DISTINCT CLICKS BEING AUDIBLE. FURTHER ANALYSIS REVEALED THAT THE OVERSHEATH, WHICH WAS RECEIVED WITH THE LENGTH CORRECT, WAS TORN SLIGHTLY AT THE DISTAL TIP. NO OTHER ISSUES WERE VISIBLE WITH THE OVERSHEATH. ANALYSIS OF THE INCIDENT DEVICE FAILED TO CONFIRM THE REPORTED EVENT THAT THE CLIP ASSEMBLY WAS NOT ABLE TO BE EXPOSED. HOWEVER, THE EVALUATION REVEALED THAT THE DISTAL END OF THE OVERSHEATH WAS TORN. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS "STUCK IN THE SHEATH" AND COULD NOT BE EXPOSED. THE DEVICE WAS REMOVED FROM WITHIN THE PATIENT AND ANOTHER RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. ON (B)(4) 2013, A VISUAL EXAMINATION, PERFORMED DURING A PRELIMINARY ANALYSIS OF THE RETURNED DEVICE, REVEALED THAT THE OVERSHEATH WAS CUT AT THE DISTAL END. THEREFORE, THIS EVENT IS NOW CONSIDERED A MDR-REPORTABLE EVENT. ADDITIONALLY, THE FULL DEVICE ANALYSIS HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113708 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000358C3

    Patients

    Seq Age Sex Outcome Treatment
    1