BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 4568479 · Received March 4, 2015

    Report

    Report Number
    1016427-2015-00014
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    February 6, 2015
    Report Date
    April 2, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    COMPLAINT CONCLUSION: AS REPORTED, THE DISTAL PORTION OF THE PGW .018 SV SHORT 180CM FRACTURED AND SEPARATED IN THE POPLITEAL ARTERY DURING A RECANALIZATION OF THE PROXIMAL TIBIAL TRUNK. THE DISTAL TIP WAS REPORTED TO HAVE REMAINED IN THE PATIENT. THE ISSUE WAS NOTED DURING REMOVAL OF THE GUIDEWIRE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ONE NON-STERILE PGW .018 SV SHORT 180CM ST WAS RECEIVED COILED INTO A PLASTIC BAG. THE CORE WIRE PRESENTED WITH A FRACTURE AT THE DISTAL END. NO OTHER ANOMALIES WERE FOUND. THE CORE WIRE WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGE WAS CONFIRMED. THE DEVICE WAS SENT TO SEM ANALYSIS. SEM CONCLUDED THAT THE CORE WIRE PRESENTED EVIDENCE OF DUCTILE DIMPLES. STRETCHING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. HOWEVER, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS INCIDENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FULLY INSPECTED AND TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DISTAL TIP - FRACTURED¿ WAS CONFIRMED DURING THE ANALYSIS. SEM RESULTS SHOWED THAT THE CORE WIRE PRESENTED WITH EVIDENCE OF DUCTILE DIMPLES. THE FLEXIBLE, DELICATE NATURE OF THE FLOPPY GUIDEWIRE TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE. FURTHERMORE, USERS ARE INSTRUCTED TO OPEN THE STERILE PACKAGE SLOWLY AND NOT TO PULL THE DISTAL TIP TO REMOVE THE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NEITHER THE DEVICE HISTORY RECORD NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE EVENT COULD BE RELATED TO THE GUIDEWIRE DESIGN OR MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LR PACKAGING L/N# 10456336, CORDIS LOT # 35223389. PER LAKE REGION REPORT C 15,369: LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING AS YET. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT WAS RETURNED FOR ANALYSIS ON 3/18/2015. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE DISTAL PORTION OF THE 180 CM. PGW SV SHORT GUIDEWIRE FRACTURED/SEPARATED IN THE POPLITEAL ARTERY DURING A RECANALIZATION OF THE PROXIMAL TIBIAL TRUNK. THE ISSUE WAS NOTED DURING REMOVAL OF THE GUIDEWIRE. THE DISTAL TIP WAS REPORTED TO HAVE REMAINED IN THE PATIENT. THE PRODUCT IS AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150640 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION UNK 35223389

    Patients

    Seq Age Sex Outcome Treatment
    1