BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIZDOM SGW

    MDR report key: 2345427 · Received November 22, 2011

    Report

    Report Number
    1016427-2011-00121
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 31, 2011
    Report Date
    November 1, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DISTAL TIP OF THE 180 CM.014 SGW WIZDOM SOFT J GUIDEWIRE APPEARED TO BE KINKED/BENT UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE PRODUCT WAS RETURNED FOR ANALYSIS. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE WIZDOM SGW WAS RECEIVED IN A PLASTIC BAG. SEVERAL BENTS WERE FOUND IN A 1CM SECTION AT APPROXIMATELY 1CM FROM TIP END. THREE KINKS WERE FOUND ON THE CORE WIRE AT 28CM, 85CM AND 159CM FROM TIP END. THE UNIT WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND THAT A 3MM SECTION WAS UNRAVELED AT APPROXIMATELY 2.4CM FROM TIP END. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10010256. THIS PACKAGING LOT CONTAINED 600 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON MAY 16, 2011. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS: "DISTAL TIP-KINKED/BENT-PRIOR TO USE" WAS CONFIRMED DUE TO THE RECEIVED CONDITION OF THE PRODUCT; MOREOVER, IT WAS OBSERVED THAT THE COIL WIRE WAS UNRAVELED AND THAT THE TIP PRESENTED SEVERAL BENDS; HOWEVER, IT IS NOT POSSIBLE TO DETERMINE THE HOW AND WHERE THIS DAMAGE OCCURRED. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT AS REPORTED. THE DHR REVIEW RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DISTAL TIP OF THE 180 CM.014 SGW WIZDOM SOFT J GUIDEWIRE APPEARED TO BE KINKED/BENT UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT. ADDENDUM: THE PRODUCT ANALYSIS NOTED: "THE UNIT WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND THAT A 3MM SECTION WAS UNRAVELED AT APPROXIMATELY 2.4CM FROM TIP END."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIZDOM SGW CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70411557

    Patients

    Seq Age Sex Outcome Treatment
    1