BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1900970 · Received November 17, 2010

    Report

    Report Number
    3005099803-2010-04746
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE SECOND OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-04745 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE STOMACH TO TREAT A POST-POLYPECTOMY GASTRIC BLEED. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE RESOLUTION CLIP WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE STOMACH TO TREAT A POST-POLYPECTOMY GASTRIC BLEED. THE NURSE GRASPED TISSUE WITH THE CLIP AND THE CLIP WAS LOCKED CLOSED; HOWEVER, UPON ATTEMPTED DEPLOYMENT, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE CLIP WAS PULLED FROM THE TISSUE AND THE ENTIRE DEVICE (CLIP AND DELIVERY CATHETER) WAS REMOVED FROM THE PATIENT. NO VISIBLE DAMAGE WAS NOTICED TO THE DEVICE AND NO TRAUMA WAS CAUSED AT THE TARGET SITE FROM THE CLIP. THIS SAME ISSUE WAS ENCOUNTERED WITH A TOTAL OF TWO RESOLUTION CLIPS DURING THIS PROCEDURE. A GOLD PROBE CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. 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 M00522612 0ML8101510

    Patients

    Seq Age Sex Outcome Treatment
    1