BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3962744 · Received July 29, 2014

    Report

    Report Number
    3005099803-2014-02661
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS DETACHED FROM THE BUSHING; HOWEVER, IT WAS STILL ATTACHED TO THE CONTROL WIRE VIA TENSION BREAKER AND YOKE. THE CLIP CAN BE DEPLOYED BUT THE CLIP PRONGS COULD NOT BE OPENED. A KINK WAS NOTED IN THE CONTROL WIRE. THE COMPLAINT THAT THE CLIP WON¿T OPEN AND CLOSE WAS CONFIRMED; HOWEVER, INVESTIGATION COULD NOT CONFIRM REPORTED EVENT OF CLIP FAILED TO RELEASE. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ABLE TO ADVANCE OUT OF THE SHEATH; HOWEVER, IT WOULD NOT OPEN OR CLOSE AND WHEN THEY ATTEMPTED TO DEPLOY THE CLIP, IT WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY, ANATOMY WAS NOT TORTUOUS AND THE CLIP DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ABLE TO ADVANCE OUT OF THE SHEATH; HOWEVER, IT WOULD NOT OPEN OR CLOSE AND WHEN THEY ATTEMPTED TO DEPLOY THE CLIP, IT WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY, ANATOMY WAS NOT TORTUOUS AND THE CLIP DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440897 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR