BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 1923710 · Received December 14, 2010

    Report

    Report Number
    1016427-2010-00151
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE UNIT OF PGW .018 SV SHORT 300CM ST WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP WAS FRACTURED AND THE COIL WAS STRETCHED AND UNRAVELED. NO OTHER VISUAL ANOMALIES WERE NOTED ON THE RECEIVED UNIT. THE DAMAGED AREA WAS OBSERVED UNDER VISION SYSTEM AND WAS SENT TO SEM ANALYSIS TO DETERMINE THE CAUSE OF THE FRACTURED. RESULTS SHOWED THAT THE FLAT CORE WIRE FRACTURE SURFACES PRESENTED EVIDENCE OF BENDING AND SMEARING CHARACTERISTICS. REVERSE BENDING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO DAMAGE TYPICAL OF THIS FAILURE MODE COULD BE OBSERVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01418417. THIS PACKAGING LOT CONTAINED 225 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JANUARY 19, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED CUSTOMER COMPLAINT OF TIP UNRAVELED/ STRETCHED AS WELL AS FRACTURED WAS CONFIRMED THROUGH FAILURE ANALYSIS. GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL. GUIDEWIRE MANIPULATION/TORQUING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE ANALYSIS, THE REPORTED INFORMATION OR THE DEVICE HISTORY REVIEW TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE PATIENT IS MALE, (B)(6), HIS LEFT ANTERIOR TIBIAL ARTERY AND FIBULAR ARTERY WERE SEVERELY STENOSIS. THE PHYSICIAN FIRST USED TEUMRO 150 GUIDEWIRE THEN CHANGED TO USE SV5, DURING THE ADVANCEMENT, THE PHYSICIAN FOUND THE TIP OF THE GUIDEWIRE WAS STRETCHED. THE PHYSICIAN CHANGED ANOTHER ONE TO COMPLETE. SO FAR THE PATIENT IS FINE. DURING PRELIMINARY EVALUATION OF THE PRODUCT THE DISTAL TIP OF THE WIRE WAS NOTED TO ALSO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70110725

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR TEUMRO 150 GUIDEWIREC, SV5 G/W