BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1801261 · Received August 16, 2010

    Report

    Report Number
    3005099803-2010-03573
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH FIELDS HAVE BEEN REVISED TO REFLECT THE CHANGE IN REPORTABILITY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT AS THE PERFORMANCE OF THE CLIP MAY HAVE LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4): ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS THE FIRST OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2010-03574, AND #3005099803-2010-03575 FOR THE ASSOCIATED DEVICE REPORTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A MUCOSECTOMY OF THE CELIAC TRUNK PERFORMED ON (B)(6), 2010. THE EVENT WAS INITIALLY REPORTED AS A FAILURE FOR THE CLIP TO RELEASE FROM THE CATHETER. CLARIFICATION FROM THE COMPLAINANT REVEALED THAT THE CLIP PROPERLY DEPLOYED INSIDE THE PATIENT AND REMAINED ATTACHED TO THE TISSUE, HOWEVER THE FAILURE WAS THAT THE PHYSICIAN WAS UNABLE TO REOPEN THE CLIP TO REPOSITION ONCE IT WAS DEPLOYED. THIS IS NOT A REPORTABLE EVENT AS THERE IS NO POTENTIAL FOR SERIOUS INJURY. A FOURTH RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED COMPLICATIONS FOR THE PATIENT.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2010-03574, AND #3005099803-2010-03575 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A MUCOSECTOMY OF THE CELIAC TRUNK PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO REOPEN THE CLIP AFTER POSITIONING THE DEVICE ON THE TISSUE. CLINICAL FOLLOW UP REVEALED THAT ALTHOUGH THE DEVICE GRASPED TISSUE, IT COULD NOT BE CONFIRMED IF THE CLIP RELEASED FROM THE TISSUE OR IF THE CLIP FAILED TO RELEASE FROM THE CATHETER AFTER IT WAS DEPLOYED INSIDE THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10051802C2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR