BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 2816894 · Received November 2, 2012

    Report

    Report Number
    1016427-2012-00138
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 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 REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT AFTER THE SGW ATW .014 STR FLOPPY 195CM GUIDEWIRE WAS REMOVED FROM THE PACKAGING, THE DISTAL TIP WAS NOTED TO BE STRETCHED. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN USED ANOTHER ONE TO COMPETE THE PROCEDURE SUCCESSFULLY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. 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 PACKAGING WAS INSPECTED PRIOR TO OPENING WITH NO DAMAGE NOTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. 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). ONE NON STERILE UNIT OF SGW ATW .014 STR FLOPPY 195CM WAS RECEIVED FOR ANALYSIS. THE DISTAL TIP PRESENTED AN UNRAVELING CONDITION. NO OTHER VISUAL DAMAGED WAS FOUND ON THE RECEIVED UNIT. SEE ATTACHED PICTURES. THE UNIT WAS OBSERVED UNDER MICROSCOPE AND NO OTHER ANOMALIES RATHER THAN THE VISUALLY DETECTED WERE OBSERVED. (B)(4). THE FAILURE REPORTED BY THE CUSTOMER AS 'DISTAL TIP - UNRAVELED/STRETCHED-PRIOR TO USE' WAS CONFIRMED AS THE RECEIVED CONDITION OF THE DEVICE, BUT IT IS NO POSSIBLE TO DETERMINE THE PLACE AND TIME OF THE DAMAGE, HOWEVER IT DOES NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT, 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; 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 AFTER THE SGW ATW .014 STR FLOPPY 195 CM GUIDEWIRE WAS REMOVED FROM THE PACKAGING, THE DISTAL TIP WAS NOTED TO BE STRETCHED. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN USED ANOTHER ONE TO COMPETE THE PROCEDURE SUCCESSFULLY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. 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 PACKAGING WAS INSPECTED PRIOR TO OPENING WITH NO DAMAGE NOTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0511231

    Patients

    Seq Age Sex Outcome Treatment
    1