BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR RETRIEVAL SNARE

    MDR report key: 1648350 · Received March 25, 2010

    Report

    Report Number
    1036710-2010-00008
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 21, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MMX
    PMA / PMN Number
    K021606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THE DISTAL END OF THE DEVICE BECAME DETACHED. A FINGER PULL TEST IS REQUIRED AT INCOMING INSPECTION OF THE CATHETER TO ENSURE THE BAND IS ASSEMBLED APPROPRIATELY. THERE WERE NO DEFECTS OR DEVIATIONS NOTED. THE SUPPLIER OF THE CATHETER WAS CONTACTED AND THEY VERIFIED THE RAW MATERIAL CATHETER WAS MANUFACTURED WITH NO DEFECTS OR DEVIATIONS NOTED. THE DEVICE WAS RETURNED BY THE CUSTOMER FOR FURTHER INVESTIGATION. THE REPORT WAS CONFIRMED. THE CATHETER IS KINKED IN MULTIPLE PLACES. ONE SNARE WIRE IS SMASHED AND DEFORMED WHICH INDICATES THE WIRE WAS PULLED WITH FORCE, OR ANOTHER DEVICE WAS USED TO DEFORM THE WIRE. FROM REVIEW OF THE SAMPLE, IT IS LIKELY THE OCCURRENCE EXPERIENCED BY THE CUSTOMER WAS DUE TO EXCESSIVE FORCE OR ABNORMAL INTERACTION DURING THE PROCEDURE. THE DFU FOR THE PRODUCT STATES THAT EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE DISTAL TIP OF THE CATHETER BECAME DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVASCULAR RETRIEVAL SNARE ENSNARE SYSTEM MMX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 392007030 80881MB9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R