BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2201287 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02749
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ALL EIGHT CLIPS ORIGINATED FROM THE FOLLOWING THREE BATCH NUMBERS: LOT # 11020704C2, DEVICE MANUFACTURE DATE: 02/24/2011, EXPIRATION DATE: 02/28/2014. LOT # 10090706C2, DEVICE MANUFACTURE DATE: 10/05/2010, EXPIRATION DATE: 09/30/2013. LOT # 10092006C2, DEVICE MANUFACTURE DATE: 10/11/2010, EXPIRATION DATE: 09/30/2013. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED 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 EIGHT COMPLAINTS THAT OCCURRED DURING THREE SEPARATE PROCEDURES. IT COULD NOT BE DETERMINED HOW MANY DEVICES WERE USED DURING EACH PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-02755, 3005099803-2011-02745, 3005099803-2011-02746, 3005099803-2011-02747, 3005099803-2011-02748, 3005099803-2011-02749, 3005099803-2011-02750, 3005099803-2011-02751. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT EIGHT RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED IN THREE SEPARATE PROCEDURES. ACCORDING TO THE COMPLAINANT, "THE CUSTOMER MET TWO PROBLEMS WITH SEVERAL CLIPS DURING DIFFERENT PROCEDURES SINCE (B)(6) 2011: DIFFICULTY RELEASING THE CLIP AND TO CLOSE SOME CLIPS." CLINICAL FOLLOW UP REVEALED THAT A TOTAL OF EIGHT RESOLUTION CLIPS WERE USED DURING THREE SEPARATE PROCEDURES; HOWEVER, IT COULD NOT BE DETERMINED HOW MANY CLIPS WERE USED DURING EACH PROCEDURE. ONE OF THE EIGHT RESOLUTION CLIPS (MANUFACTURER REPORT # 3005099803-2011-02755) FAILED TO RELEASE FROM THE DELIVERY SYSTEM AND RESULTED IN ADDITIONAL BLEEDING. THE PHYSICIAN WAS ABLE TO STOP THE BLEED WITH THE USE OF AN ADDITIONAL CLIP. THE SEVEN REMAINING COMPLAINT RECORDS HAVE ALL BEEN DEEMED MDR REPORTABLE EVENTS AS IT IS UNKNOWN IF THE FAILURE WAS "DIFFICULT TO RELEASE" OR "WON'T OPEN/CLOSE" FOR EACH EVENT. ALTHOUGH CLINICAL FOLLOW UP WAS RECEIVED FOR THESE COMPLAINTS; SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER CLARIFICATION ON THIS EVENT AND THE DETAILS SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1