BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2992834 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01231
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. 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 AN EGD (ESOPHAGOGASTRODUODENOSCOPY). ACCORDING TO THE COMPLAINANT, A J TUBE WAS BEING PLACED WITHIN THE JEJUNUM. DURING THE PROCEDURE, THE CLIP WAS ADVANCED TO THE TARGET SITE AND LOCKED ONTO THE TISSUE HOWEVER; THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. REPORTEDLY, THERE WAS NO TEARING OR INJURY TO THE TISSUE. THE DEVICE WAS REMOVED FROM WITHIN THE PATIENT AND ANOTHER RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE CASE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96889 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610

    Patients

    Seq Age Sex Outcome Treatment
    1