BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3061019 · Received April 16, 2013

    Report

    Report Number
    3005099803-2013-02336
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EXAMINATION NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. THERE WAS A KINK IN THE CONTROL WIRE AND THE COIL WAS KINKED AT THE BUSHING. FUNCTIONAL ANALYSIS REVEALED THAT THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NOT BE OPENED OR CLOSED. THE PRONGS WERE NOT LOCKED INTO THE CAPSULE. INVESTIGATION FOUND THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AS THE CLIP WAS MASHED ONTO THE BUSHING, THE COIL WAS KINKED AT THE BUSHING, AND THE CONTROL WIRE WAS KINKED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE WAS CONFIRMED. IT IS LIKELY THAT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT - CLIP WOULD NOT RELEASE FROM CATHETER. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A RESOLUTION CLIP WAS USED DURING A PROCEDURE TO TREAT A GASTRIC BLEED PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE CLIP WAS CLOSED ON THE BLEED BUT DID NOT DETACH FROM THE CATHETER. THE SCOPE WAS MANIPULATED TO EFFECT DETACHMENT OF THE CLIP FROM THE MUCOSA. ONCE THE CLIP DETACHED FROM THE MUCOSA, THE CATHETER WAS WITHDRAWN WITH THE CLIP STILL ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A RESOLUTION CLIP WAS USED DURING A PROCEDURE TO TREAT A GASTRIC BLEED PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE CLIP WAS CLOSED ON THE BLEED BUT DID NOT DETACH FROM THE CATHETER. THE SCOPE WAS MANIPULATED TO EFFECT DETACHMENT OF THE CLIP FROM THE MUCOSA. ONCE THE CLIP DETACHED FROM THE MUCOSA, THE CATHETER WAS WITHDRAWN WITH THE CLIP STILL ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162075 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000414C3

    Patients

    Seq Age Sex Outcome Treatment
    1