BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOURNEY¿

    MDR report key: 2220463 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03423
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 26, 2011
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: ORIGINALLY IT WAS REPORTED AS OPERATIONAL CONTEXT. CORRECTED TO: THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT - 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: MAGNIFIED INSPECTION REVEALED THAT THE DISTAL SOLDER TIP WAS MISSING. THE RADIOPAQUE COIL AND INCONEL SHAPING RIBBON WERE VISIBLE IN THEIR APPROPRIATE RESPECTIVE LOCATIONS WITHIN THE WIRE. A THOROUGH INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. VISUAL INSPECTION CONFIRMED A DISTAL SOLDER TIP DETACHMENT. ANALYTICAL TESTING CONCLUDED THAT SOLDER MATERIAL WAS PRESENT AT THE DISTAL END OF THE GUIDEWIRE, ON THE CORE WIRE TIP AND INCONEL SHAPING RIBBON. POTENTIAL CAUSES OF COMPONENT SEPARATION INCLUDE MATERIAL PROPERTIES, BOND STRENGTH AND APPLIED FORCES DURING HANDLING OR USE OF THE DEVICE. CONTROLS AND PREVENTIVE MEASURES INTENDED TO MITIGATE THE RISK OF SOLDER JOINT DETACHMENT (B)(4) AND A FINAL VISUAL INSPECTION. JOURNEY STR IN PROCESS MONITORING INCLUDES 100% FULL LENGTH TENSILE, TIP SOLDER SHEAR, COUPLE WELD TENSILE, COUPLER WELD FATIGUE AND 100% VISUAL INSPECTION. AGGRESSIVE SHAPING OF THE DISTAL TIP THAT EXCEEDS THE (B)(4) SPECIFICATION COULD CAUSE THE SOLDER JOINT TO DETACH. IT IS NOTABLE THAT THE REPORTED INFORMATION INDICATES THAT THE COMPLAINT DEVICE DID NOT ENTER THE PATIENT AT ANY POINT DURING THE PROCEDURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2011. IT WAS REPORTED THAT DURING UNPACKING A KINK WAS NOTED. AS THE JOURNEY, STR, 300CM WAS BEING UPACKED A KINK WAS NOTED A COUPLE OF CENTIMETERS FROM THE DISTAL END. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE BALL WAS MISSING ON THE DISTAL TIP.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING UNPACKING A KINK WAS NOTED. AS THE JOURNEY, STR, 300CM WAS BEING UNPACKED A KINK WAS NOTED A COUPLE OF CENTIMETERS FROM THE DISTAL END. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE BALL WAS MISSING ON THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY¿ WIRE, GUIDE, CATHETER DQX M001391280 13751775

    Patients

    Seq Age Sex Outcome Treatment
    1