BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2083430 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01655
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01656. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT AN UPPER GI BLEED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE RESOLUTION CLIP WOULD NOT SEPARATE FROM THE CATHETER ON THE THIRD DEPLOYMENT STEP. THE PHYSICIAN HAD TO MANIPULATE THE SCOPE AND EVENTUALLY IT SEPARATED FROM THE DELIVERY CATHETER. A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01656) WAS USED AND THE SAME ISSUE OCCURRED. THE CLIP WOULD NOT SEPARATE FROM THE CATHETER ON THE THIRD DEPLOYMENT STEP. THE PHYSICIAN HAD TO MANIPULATE THE SCOPE AND EVENTUALLY IT SEPARATED FROM THE DELIVERY CATHETER. THE PHYSICIAN USED A THIRD RESOLUTION CLIP TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 0ML9091804

    Patients

    Seq Age Sex Outcome Treatment
    1