BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW GUIDEWIRE (ALSO CALLED OSD)

    MDR report key: 4240387 · Received November 10, 2014

    Report

    Report Number
    1016427-2014-00115
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    August 23, 2014
    Report Date
    October 31, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT PRODUCT. (B)(6). THE GENDER OF THE PATIENT IS UNKNOWN. COMPLAINT CONCLUSION: A .014 ATW J FLOPPY 300CM GUIDE WIRE TIP WAS STRETCHED AT AN UNKNOWN POINT. THERE WAS NO PATIENT INJURY REPORTED. THE EVENT DID NOT OCCUR DURING THE PROCEDURE/SURGERY. EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THE DISTAL CORE WIRE WAS FOUND FRACTURED. ONE NON STERILE GUIDEWIRE SGW ATW .014 J FLOPPY 300CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP WAS FOUND UNRAVELED/STRETCHED. THE DISTAL CORE WIRE WAS FOUND FRACTURED. NO OTHER ANOMALIES WERE OBSERVED. SEM RESULTS SHOWED THAT THE CORE WIRE PRESENTED EVIDENCE OF ELONGATION AND DUCTILE DIMPLE. STRETCHING AND/OR PULLING 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. LR PACKAGING L/N # 10239793, (B)(6); PER (B)(6): (B)(6) MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10239793. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURES BY THE CUSTOMER AS ¿GUIDEWIRE - UNRAVELED/STRETCHED¿ WAS CONFIRMED OWING TO RECEIVED CONDITION OF THE DEVICE; ALSO, IT WAS OBSERVED THAT THE DISTAL SECTION OF THE CORE WIRE WAS FRACTURED. THE EXACT CAUSE OF THE REPORTED ISSUE AS WELL AS OF THE FRACTURED CORE WIRE CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE SEM RESULTS SUGGESTED THAT PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURES AS REPORTED. ALSO, 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. 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.

    Description of Event or Problem · 1

    AS REPORTED, A .014 ATW J FLOPPY 300CM GUIDE WIRE TIP WAS STRETCHED AT AN UNKNOWN POINT. THERE WAS NO PATIENT INJURY REPORTED. THE EVENT DID NOT OCCUR DURING THE PROCEDURE/SURGERY. EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THE DISTAL CORE WIRE WAS FOUND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722006 ATW GUIDEWIRE (ALSO CALLED OSD) CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION 595Y014 F0213171

    Patients

    Seq Age Sex Outcome Treatment
    1