BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2832352 · Received November 14, 2012

    Report

    Report Number
    3005099803-2012-05390
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE OVERSHEATH WITH BLUE SHEATH GRIP WAS NOT RECEIVED WITH THE RETURNED DEVICE. FUNCTIONALLY, THE CLIP ASSEMBLY WAS ABLE TO BE ACTUATED AND DEPLOYED; TWO DISTINCTIVE CLICKS WERE AUDIBLE. DURING ACTUATION, THE PRONGS OPENED TO APPROXIMATELY 11MM. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN. HOWEVER, THE PATIENT WAS OVER 18 YEARS OLD. THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS TO BE USED FOR HEMOSTASIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, WITHIN THE STOMACH, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE USER "CLOSED THE CLIP AND PULLED THE SCOPE BACK," BUT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. REPORTEDLY, THE SCOPE WAS NOT IN A RETROFLEX POSITION AND NO PROCEDURAL DELAY OCCURRED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS TO BE USED FOR HEMOSTASIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, WITHIN THE STOMACH, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE USER "CLOSED THE CLIP AND PULLED THE SCOPE BACK," BUT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. REPORTEDLY, THE SCOPE WAS NOT IN A RETROFLEX POSITION AND NO PROCEDURAL DELAY OCCURRED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000346C3

    Patients

    Seq Age Sex Outcome Treatment
    1