BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2173379 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02501
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 USED DURING A COLONOSCOPY WITH POLYP REMOVAL PROCEDURE, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE IN THE TRANSVERSE COLON, THEY ATTACHED THE CLIP TO DESIRED TARGET AREA HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE CLIP WAS PULLED OFF THE TISSUE AND IT DID NOT CAUSE ANY EXTRA BLEEDING OR TISSUE DAMAGE. THE CASE WAS COMPLETED WITH TWO ADDITIONAL RESOLUTION CLIP DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10052602C2

    Patients

    Seq Age Sex Outcome Treatment
    1