BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFORM GUIDEWIRE - SAFARI

    MDR report key: 4914876 · Received July 13, 2015

    Report

    Report Number
    2126666-2015-00041
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    May 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    LAKE REGION MFG., INC.
    Product Code
    DQX
    PMA / PMN Number
    K130798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2015. THE RETURNED SPECIMEN WAS NOT USED IN A PATIENT. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. LOT RELEASE TESTING INCLUDES NON-DESTRUCTION 100% PROOF TESTING OF THE JOINTS, IN ADDITION TO AN AQL SAMPLING DESTRUCTIVE PULL TEST. THE REPORT OF DAMAGE IS CONFIRMED. THE SPECIMEN PRESENTS APPROX. 1.50CM OF THE PROXIMAL END OF THE CORE WIRE EXTENDING THROUGH THE COIL WRAPS APPROX. 35.8 CM FROM THE PROXIMAL END. THE DISTAL ASPECT OF THE PROXIMAL CORE-TO-CORE WIRE WELD JOINT WAS EXPOSED BY STRETCHING THE ADJACENT COIL WRAP. EXAMINATION OF THE PROXIMAL END OF THE CORE WIRE AND THE DISTAL ASPECT OF THE PROXIMAL WELD MASS REVEALS A DUCTILE, TENSILE OVERLOAD OF THE JOINT. THE SPECIMEN ALSO PRESENTS A KINK 77.0 TO 77.2CM FROM THE DISTAL APEX OF THE SPIRAL CURVE, OFFSET/MIS-ALIGNED COIL WRAPS 21.2 TO 22.3CM FROM THE PROXIMAL END, AND SEVERAL IRREGULAR REGIONS OF STRETCHED COIL DAMAGE SCATTERED OVER THE LENGTH OF THE DEVICE. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. THE DISTAL JOINT APPEARS TO BE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NON-DESTRUCTION TESTING. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE AND THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION IT APPEARS THAT HANDLING FACTORS MAY BE CONTRIBUTED TO THE EVENT AS REPORTED.

    Description of Event or Problem · 1

    THE NURSE INFORMED ME THAT ONE SAFARI WIRE WAS DELIVERED IN A MALFUNCTIONING STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452929 PREFORM GUIDEWIRE - SAFARI WIRE GUIDE DQX LAKE REGION MFG., INC. H74939271S1 10488774

    Patients

    Seq Age Sex Outcome Treatment
    1