BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2173041 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02495
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 27, 2011
    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

    THE PATIENT'S EXACT AGE IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 THERE WAS A KINK IN THE CONTROL WIRE. IN ADDITION, THE CLIP ASSEMBLY WAS DEPLOYED AND NOT RETURNED. THE EVENT THAT THE CLIP HAD DIFFICULTY RELEASING FROM THE CATHETER COULD NOT BE CONFIRMED, AS THE CLIP ASSEMBLY WAS DEPLOYED AND NOT RETURNED. THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE, AS EVIDENT OF THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED ONTO TISSUE HOWEVER, THEY HAD DIFFICULTY GETTING THE CLIP TO RELEASE FROM THE CATHETER. THE PHYSICIAN TUGGED ON THE CLIP AND THE CLIP RELEASED FROM THE CATHETER HOWEVER, THE CLIP DID REMAIN ON THE TISSUE. THIS CLIP WAS ENOUGH TO COMPLETE THE PROCEDURE; THEREFORE THE CASE WAS COMPLETED WITH THIS 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED ONTO TISSUE HOWEVER, THEY HAD DIFFICULTY GETTING THE CLIP TO RELEASE FROM THE CATHETER. THE PHYSICIAN TUGGED ON THE CLIP AND THE CLIP RELEASED FROM THE CATHETER HOWEVER, THE CLIP DID REMAIN ON THE TISSUE. THIS CLIP WAS ENOUGH TO COMPLETE THE PROCEDURE; THEREFORE THE CASE WAS COMPLETED WITH THIS 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000032C2

    Patients

    Seq Age Sex Outcome Treatment
    1