BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1802467 · Received August 17, 2010

    Report

    Report Number
    3005099803-2010-03437
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT EXACT PATIENT AGE IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS (B)(6) OLD. 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

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-03438 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE FOUND TO HAVE AN ISSUE DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO CLIPS GRASPED ONTO THE TISSUE HOWEVER, THE CLIPS WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN PULLED THE CLIPS OFF THE TISSUE WITHOUT CAUSING ANY DAMAGE TO THE TISSUE. EACH DEVICE WAS REMOVED FROM THE PATIENT AND NO VISUAL DAMAGE TO EITHER DEVICE WAS NOTICED. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. IT WAS ALSO REPORTED THAT THE ESTIMATED DELAY IN THE PROCEDURE WAS APPROXIMATELY 10 MINUTES AND THAT THE DELAY DID NOT EXACERBATE THE BLEED. 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
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10021603C2

    Patients

    Seq Age Sex Outcome Treatment
    1