BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2111759 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01881
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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 #'S 3005099803-2011-01881 AND 3005099803-2011-01882. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A POST POLYPECTOMY BLEED IN THE RECTUM DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY PROCEDURE WITH POLYPECTOMY, THE MUCOSA STARTED TO BLEED POST POLYPECTOMY. THE PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTION CLIP AT THE TARGET SITE TO STOP THE BLEED; HOWEVER, DURING DEPLOYMENT THE PHYSICIAN NOTICED THAT THE CLIP WAS BROKEN AND ONLY ONE PRONG ATTACHED TO THE MUCOSA AND THE OTHER PRONG WAS LOOSE. ANOTHER RESOLUTION CLIP (MANUFACTURER REPORT #3005099803-2011-01882) WAS USED AND THE SAME ISSUE OCCURRED. THE CLIP WAS BROKEN AND ONLY ONE PRONG ATTACHED TO THE MUCOSA. CLINICAL FOLLOW UP REVEALED THAT THE TWO BROKEN CLIPS EVENTUALLY FELL OFF THE TISSUE AND WERE LEFT IN THE PATIENT TO PASS NATURALLY. THE PHYSICIAN USED THREE ADDITIONAL CLIPS TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION 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 10101905C2

    Patients

    Seq Age Sex Outcome Treatment
    1