BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER RADIOLUCENT

    MDR report key: 1993997 · Received February 16, 2011

    Report

    Report Number
    1016427-2011-00016
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED STATED THAT THE GUIDEWIRE WOULD NOT CROSS THE TARGET LESION DURING THE PROCEDURE. THE WIRE WAS RETURNED FOR EVALUATION AND ANALYSIS NOTED THAT TWO KINKED CONDITIONS WERE NOTED ON THE DEVICE, THE FIRST WAS AT 1.5CM FROM DISTAL END THE SECOND WAS AT 36CM FROM THE PROXIMAL END. THE KINKED CONDITIONS WERE INSPECTED UNDER A MICROSCOPE AND THE SECOND KINKED AREA PRESENTED THE PTFE WAS PEELED. IT IS UNKNOWN IF A TORQUE DEVICE HAD BEEN USED. ONE NON STERILE SGW STABLIZR .014 180CM J SS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. TWO KINKED CONDITION WERE NOTED ON THE DEVICE, THE FIRST WAS AT 1.5CM FROM DISTAL END THE SECOND WAS AT 36CM FROM THE PROXIMAL END. THE KINKED CONDITIONS WERE INSPECTED UNDER A MICROSCOPE AND THE SECOND KINKED AREA PRESENTED THE PTFE PEELED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE REPORTED FAILURE BY THE CUSTOMER AS ''GUIDEWIRE-FAILURE TO CROSS'' COULD NOT BE EVALUATED DUE TO THE NATURE OF THE COMPLAINT, HOWEVER, THIS EVENT DOES NOT APPEAR TO BE MANUFACTURING RELATED TO THE PRODUCT; IT IS LIKELY THAT PROCEDURAL FACTOR MAY HAVE CONTRIBUTED TO THIS FAILURE. THE CAUSE OF THE DAMAGES OBSERVED ON THE DEVICE COULD NOT BE DETERMINED, PROCEDURAL/HANDLING FACTOR MAY HAVE CONTRIBUTED TO THIS DAMAGE. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT SHIPPING/HANDLING, VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE PEELING OF THE PTFE.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CONCLUSION IN THE INITIAL MED WATCH REPORT WAS INADVERTENTLY SENT WITH INCORRECT INFORMATION. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. THE CONCLUSION HAS BEEN AMENDED TO REFLECT THE CORRECT INFORMATION: THE REPORT RECEIVED STATED THAT THE GUIDEWIRE WOULD NOT CROSS THE TARGET LESION DURING THE PROCEDURE. THE WIRE WAS RETURNED FOR EVALUATION AND ANALYSIS NOTED THAT TWO KINKED CONDITIONS WERE NOTED ON THE DEVICE, THE FIRST WAS AT 1.5 CM FROM DISTAL END THE SECOND WAS AT 36 CM FROM THE PROXIMAL END. THE KINKED CONDITIONS WERE INSPECTED UNDER A MICROSCOPE AND THE SECOND KINKED AREA PRESENTED THE PTFE WAS PEELED. IT IS UNKNOWN IF A TORQUE DEVICE HAD BEEN USED. ONE NON STERILE SGW STABILIZER .014 180 CM J SS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. TWO KINKED CONDITION WERE NOTED ON THE DEVICE, THE FIRST WAS AT 1.5 CM FROM DISTAL END THE SECOND WAS AT 36 CM FROM THE PROXIMAL END. THE KINKED CONDITIONS WERE INSPECTED UNDER A MICROSCOPE AND THE SECOND KINKED AREA PRESENTED THE PTFE PEELED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE REPORTED FAILURE BY THE CUSTOMER AS "GUIDEWIRE-FAILURE TO CROSS" COULD NOT BE EVALUATED DUE TO THE NATURE OF THE COMPLAINT, HOWEVER THIS EVENT DOES NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT; IT IS LIKELY THAT PROCEDURAL FACTOR MAY HAVE CONTRIBUTED TO THIS FAILURE. THE CAUSE OF THE DAMAGES OBSERVED ON THE DEVICE COULD NOT BE DETERMINED, PROCEDURAL/HANDLING FACTOR MAY HAVE CONTRIBUTED TO THIS DAMAGE. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT SHIPPING/HANDLING, VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE PEELING OF THE PTFE. PLEASE NOTE THAT THIS INFORMATION DOES NOT CHANGE THE EVALUATION.

    Description of Event or Problem · 1

    THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE SGW STABLIZR .014 180CM J SS WOULD NOT CROSS THE TARGET LESION DURING THE PROCEDURE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WHICH WAS TORTUOUS IN NATURE. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM THE PACKAGING. FEMORAL ACCESS. THE GUIDEWIRE WAS NOT KINKED OR BENT. THE TIP OF THE GUIDEWIRE WAS NOT PRE-SHAPED. ANOTHER GUIDE WIRE WAS USED AND THE PROCEDURE WAS DONE SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE WIRE WAS RETURNED FOR EVALUATION AND ANALYSIS NOTED THAT TWO KINKED CONDITIONS WERE NOTED ON THE DEVICE, THE FIRST WAS AT 1.5CM FROM DISTAL END THE SECOND WAS AT 36CM FROM THE PROXIMAL END. THE KINKED CONDITIONS WERE INSPECTED UNDER A MICROSCOPE AND THE SECOND KINKED AREA PRESENTED THE PTFE PEELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER RADIOLUCENT CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 71009799

    Patients

    Seq Age Sex Outcome Treatment
    1