BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5753798 · Received June 27, 2016

    Report

    Report Number
    0002090040-2016-00009
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 7, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    PMA / PMN Number
    K012688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, KINKS WERE IDENTIFIED APPROXIMATELY 5 CM AND 8 CM FROM THE DISTAL TIP, WHICH ARE DISTAL TO THE TRANSITION POINT. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE KINKS LEADING TO AN IMPROPER CURVE AS A RESULT OF MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER. THE INSTRUCTIONS FOR USE STATE: 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 MANUAL PRE-BENDING OF DISTAL CURVE, AS THIS MAY DAMAGE STEERING MECHANISM OF STEERABLE CATHETERS. 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. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT FEMORAL VEIN ACCESS THROUGH SHORT 6F JSN, THE DEVICE CURLED AND KNOTTED IN INTERIOR VENA CAVA. THEY WERE UNABLE TO ADVANCE OR WITHDRAW AND VEIN ACCESS LOST DUE TO CATHETER REMOVAL. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408109 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 400007 2721414SH

    Patients

    Seq Age Sex Outcome Treatment
    1