BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2891123 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06364
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS DETACHED FROM THE BUSHING, BUT STILL ATTACHED TO THE CONTROL WIRE, VIA THE TENSION BREAKER AND YOKE. FUNCTIONALLY, THE PRONGS COULD NOT BE OPENED, BUT THE CLIP ASSEMBLY COULD BE DEPLOYED. TWO CLICKS WERE HEARD. IT WAS ALSO NOTICED THAT THERE WAS A KINK IN THE CONTROL WIRE AND THE TABS WERE PARTIALLY OPEN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE CONDITION OF THE RETURNED INCIDENT DEVICE CAN CAUSE DIFFICULTY IN RELEASING THE CLIP FROM THE CATHETER, WHICH IS CONSISTENT WITH THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP DEVICE WAS LOCKED ONTO TISSUE, HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING 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 DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP DEVICE WAS LOCKED ONTO TISSUE, HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000397C3

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR