BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 8700415 · Received June 14, 2019

    Report

    Report Number
    0002090040-2019-00018
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    April 12, 2019
    Report Date
    June 14, 2019
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    UDI-DI
    00885825005894
    PMA / PMN Number
    K030026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON VISUAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE, A KINK WAS IDENTIFIED 4.5 CM FROM THE DISTAL TIP OF THE DEVICE. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSE IS A BEND DISTAL TO THE TRANSITION POINT AS A RESULT OF MISHANDLING, INCLUDING SHIPPING AND STORAGE CONDITIONS, SUBSEQUENT TO DISTRIBUTION FROM STRYKER. THE INSTRUCTIONS FOR USE (IFU) STATE: DO NOT INTRODUCE THE TIP FOLDED INTO THE GUIDING SHEATH. DO NOT EXERT EXCESSIVE PRESSURE DURING PLACEMENT OF CATHETER IF UNKNOWN RESISTANCE IS ENCOUNTERED. DO NOT ATTEMPT TO USE THE REPROCESSED EP CATHETER PRIOR TO COMPLETELY READING AND UNDERSTANDING THE DIRECTIONS FOR USE. AVOID EXCESSIVE TORQUE, STRETCHING, KINKING AND/OR BENDING OF CATHETER, AS THIS MAY INTERFERE WITH DISTAL TIP SHAPING OR CAUSE DAMAGE TO INTERNAL ELECTRODE WIRES. DO NOT ALTER THIS DEVICE. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JSN ELECTROPHYSIOLOGY CATHETER IS FAULTY. THE COMPLAINANT IS UNAWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492021 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 401261 3799744 00885825005894

    Patients

    Seq Age Sex Outcome Treatment
    1