BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW GUIDEWIRE

    MDR report key: 2759972 · Received September 26, 2012

    Report

    Report Number
    1016427-2012-00123
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    November 7, 2011
    Report Date
    September 4, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE DISTAL TIP OF THE ATW GUIDEWIRE/SGW ATW .014 STR FLOPPY 195CM WAS BROKEN AFTER IT WAS REMOVED FROM THE PACKAGING. THE PACKAGING WAS INTACT BEFORE IT WAS OPENED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE GUIDEWIRE SGW ATW .014 STR FLOPPY 195CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP WAS FOUND UNRAVELED, AND THE COIL WIRE WAS FRACTURED/ SEPARATED FROM THE CORE WIRE. NO OTHER ANOMALIES WERE OBSERVED. SEM ANALYSIS WAS PERFORMED FOR THE SGW ATW GUIDE WIRE DEVICE TO DETERMINE THE CAUSE OF THE FRACTURE; RESULTS SHOWED THAT THE CORE WIRE PRESENTED EVIDENCE OF SMEARING; THE COIL WIRE PRESENTED EVIDENCE OF DUCTILE DIMPLES AND TWISTING. PULLING/ STRETCHING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. (B)(4). THE REPORTED FAILURE BY THE CUSTOMER AS 'DISTAL TIP - FRACTURED-PRIOR TO USE' WAS CONFIRMED OWING TO RECEIVED CONDITION OF THE DEVICE. THE EXACT CAUSE OF THE REPORTED ISSUE BY CUSTOMER AS WELL AS THE COIL UNRAVELING CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY THAT COULD BE CONTRIBUTED TO THE EVENTS AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. 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). NEITHER THE PRODUCT ANALYSIS NOR THE SEM ANALYSIS SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE GUIDEWIRE MANUFACTURING PROCESS; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE DISTAL TIP OF THE ATW GUIDEWIRE/SGW ATW .014 STR FLOPPY 195CM WAS BROKEN AFTER IT WAS REMOVED FROM THE PACKAGING. THE PACKAGING WAS INTACT BEFORE IT WAS OPENED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0411809

    Patients

    Seq Age Sex Outcome Treatment
    1