BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL ACCESS CATHETER, 057 X 115 CM

    MDR report key: 1886751 · Received October 15, 2010

    Report

    Report Number
    2954917-2010-00013
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAC INSTRUCTIONS FOR USE LISTS VESSEL PERFORATION AND HEMORRHAGE AS POSSIBLE COMPLICATIONS. THE IFU ALSO INCLUDES THE FOLLOWING WARNINGS THAT ARE APPLICABLE TO THIS REPORT: NEVER ADVANCE CATHETER AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF CAUSE USING FLUOROSCOPY. IF CAUSE CANNOT BE DETERMINED, WITHDRAW CATHETER. MOVEMENT AGAINST RESISTANCE MAY RESULT IN CATHETER DAMAGE OR PT INJURY. DO NOT USE DEVICE THAT HAS BEEN DAMAGED IN ANY WAY. DAMAGED DEVICE MAY CAUSE COMPLICATIONS. IF INTRALUMINAL DEVICE BECOMES LODGED IN CATHETER, OR IF THE CATHETER BECOMES SEVERELY KINKED, WITHDRAW THE ENTIRE SYSTEM (INTRALUMINAL DEVICE, CATHETER AND INTRODUCER SHEATH). ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A DISTAL ACCESS CATHETER (DAC) FOR PROXIMAL SUPPORT FOR EMBOLIZATION OF A VERY DISTAL AVM. HE STATED THAT THE DAC "CRIMPED" DURING INITIAL ACCESS AND MADE MICROCATHETER AND GUIDEWIRE MANIPULATION DIFFICULT. HE EVENTUALLY REMOVED THE DAC AND PROCEEDED TO EMBOLIZED THE AVM WITHOUT THE DAC. AFTER THE PROCEDURE, THE PT HAD A SUBARACHNOID HEMORRHAGE. THE PHYSICIAN INDICATED THAT HIS DIFFICULTIES MANIPULATING THE GUIDEWIRE CAUSED THE GUIDEWIRE TO PERFORATE THE VESSEL. THE PHYSICIAN INDICATED THAT THE PT IS CURRENTLY DOING "OK" BUT HAD TO SPEND 3 EXTRA DAYS IN THE HOSPITAL DUE TO THE COMPLICATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS SO IT WAS NOT POSSIBLE TO PERFORM AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL ACCESS CATHETER, 057 X 115 CM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| O