BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW GUIDEWIRE (ALSO CALLED OSD)

    MDR report key: 3031386 · Received April 2, 2013

    Report

    Report Number
    1016427-2013-00037
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY/PTA, THE 300 CM. SGW ATW J FLOPPY .014 GUIDEWIRE BECAME KINKED AFTER INSERTION INTO THE SUPERFICIAL FEMORAL ARTERY (SFA) AND ANALYSIS REVEALED THAT THE CORE WIRE OF THE DISTAL TIP WAS FRACTURED. THE SFA LESION WAS REPORTED TO BE HIGHLY CALCIFIED. THE GUIDEWIRE WAS REMOVED AND ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU WITH NO PROBLEMS NOTED DURING PREPARATION. THERE WAS NO OTHER REPORTED PRODUCT ISSUE NOTED UPON INSPECTION POST-PROCEDURE OR PRIOR TO SHIPPING FOR INSPECTION. ONE NON-STERILE GUIDEWIRE SGW ATW .014 J FLOPPY 300CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP WAS FOUND UNRAVELED AND KINKED. THE DISTAL CORE WIRE WAS FOUND FRACTURED. NO OTHER ANOMALIES WERE OBSERVED. SEM ANALYSIS REVEALED THAT THE CORE WIRE PRESENTED EVIDENCE OF SMEARING AND REVERSE BENDING CONDITIONS. THESE TYPES OF FAILURES OCCUR DUE TO THE APPLICATION OF FLUCTUATING STRESSES THAT ARE MUCH LOWER THAN THE STRESS REQUIRED TO CAUSE FAILURE DURING A SINGLE APPLICATION OF STRESS. FATIGUE IS A PROBLEM THAT CAN AFFECT ANY PART OR COMPONENT THAT MOVES. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURES BY THE CUSTOMER AS 'GUIDEWIRE - KINKED/BENT-IN PATIENT' AND 'DISTAL TIP - FRACTURED-IN PATIENT' WERE CONFIRMED OWING TO RECEIVED CONDITION OF THE DEVICE. THE EXACT CAUSE OF THE REPORTED ISSUES BY CUSTOMER, AS WELL AS THE COIL UNRAVELING CONDITION, COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE SEM RESULTS AND THE EVENT DESCRIPTION SUGGESTED THAT PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURES AS REPORTED. THE FLEXIBLE, "DELICATE" NATURE OF THE "FLOPPY" TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). TIP FRACTURES HAVE BEEN REPORTED IN PROCEDURES INVOLVING GUIDEWIRE ENTRAPMENT, TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. THE IFU WARNS TO "NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR.' IN ADDITION, "IF ANY RESISTANCE IS FELT, I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT, WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THIS MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY THAT COULD BE CONTRIBUTED TO THE EVENTS AS REPORTED AND THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT, THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY/PTA, THE 300 CM. SGW ATW J FLOPPY .014 GUIDEWIRE BECAME KINKED AFTER INSERTION INTO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA LESION WAS REPORTED TO BE HIGHLY CALCIFIED. THE GUIDEWIRE WAS REMOVED AND ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU WITH NO PROBLEMS NOTED DURING PREPARATION. THERE WAS NO OTHER REPORTED PRODUCT ISSUE NOTED UPON INSPECTION POST-PROCEDURE OR PRIOR TO SHIPPING FOR INSPECTION. ADDENDUM: PRELIMINARY ANALYSIS INDICATED THAT THE CORE WIRE OF THE DISTAL TIP WAS NOTED TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133582 ATW GUIDEWIRE (ALSO CALLED OSD) CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F1111247

    Patients

    Seq Age Sex Outcome Treatment
    1