BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2183192 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02517
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02516 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLON POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AFTER REMOVING A MEDIUM TO LARGE POLYP, THE PHYSICIAN CHOSE TO CLOSE THE DEFECT. A CLIP WAS ADVANCED TO THE SITE AND THE TISSUE WAS GRASPED. HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO SEPARATE THE CLIP FROM THE CATHETER. AFTER SOME MANIPULATION, THE CLIP DETACHED AND REMAINED ATTACHED TO THE TISSUE. A SECOND CLIP WAS THEN USED AND POSITIONED ALONGSIDE THE FIRST, BUT THE SAME ISSUE RECURRED. THE CLIP WAS DIFFICULT TO RELEASE FROM THE CATHETER, BUT WITH SOME MANIPULATION DETACHED. THE PROCEDURE WAS COMPLETED AFTER PLACING THE SECOND RESOLUTION CLIP DEVICE. 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 CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 0ML9053112

    Patients

    Seq Age Sex Outcome Treatment
    1