BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6194172 · Received December 21, 2016

    Report

    Report Number
    0002090040-2016-00020
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 21, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    UDI-DI
    00885825007355
    PMA / PMN Number
    K052603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 APPROXIMATELY 14CM FROM THE DISTAL TIP, WHICH IS 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 THE DOCTOR HAD TROUBLE STEERING THE DEVICE INTO THE CORONARY SINUS DURING AN AFIB PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844594 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 401932 2973279SH 00885825007355

    Patients

    Seq Age Sex Outcome Treatment
    1