BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3232890 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-07182
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE DEVICE WAS FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED. THE PRODUCT ANALYSIS ALSO INDICATES THAT THERE WAS A KINK IN THE COIL AND CONTROL WIRE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE MAY HAVE BEEN 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. 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 ON (B)(6) 213 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP WAS DEPLOYED ONTO THE SITE; HOWEVER, THE CLIP COULD NOT BE RELEASED FROM THE CATHETER. THE OPERATOR NEEDED TO CUT THE CATHETER. THERE WAS NO REPORTED INFORMATION REGARDING PATIENT COMPLICATIONS AS A RESULT OF THIS PROCEDURE. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THIS PROCEDURE WAS REPORTED TO BE UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, 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 DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP WAS DEPLOYED ONTO THE SITE; HOWEVER, THE CLIP COULD NOT BE RELEASED FROM THE CATHETER. THE OPERATOR NEEDED TO CUT THE CATHETER. THERE WAS NO REPORTED INFORMATION REGARDING PATIENT COMPLICATIONS AS A RESULT OF THIS PROCEDURE. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THIS PROCEDURE WAS REPORTED TO BE UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333470 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000423C3

    Patients

    Seq Age Sex Outcome Treatment
    1