BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6106429 · Received November 16, 2016

    Report

    Report Number
    2024168-2016-07999
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 18, 2016
    Report Date
    March 30, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151880
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE RETURNED FOR ANALYSIS. THE COMPLAINT INVESTIGATION DETERMINED THE REPORTED DIFFICULTY WAS CONFIRMED AND THE ISSUE WAS DETERMINED TO BE RELATED TO MANUFACTURING ISSUES ASSOCIATED WITH THE PROTECTIVE SHEATH. ON MARCH 14, 2017, ABBOTT VASCULAR DECIDED TO INITIATE A VOLUNTARY FIELD ACTION FOR SOME SIZES AND LOTS OF THE NC TREK FAMILY OF DILATATION CATHETERS FOR DIFFICULTY TO REMOVE SHEATH WHICH MAY LEAD TO INFLATION OR DEFLATION ISSUES. ABBOTT VASCULAR PERFORMED A COMPREHENSIVE INVESTIGATION WHICH INCLUDED DEVICE ANALYSIS, MANUFACTURING EVALUATION AND TREND ANALYSIS. THE ROOT CAUSE IDENTIFICATION WAS COMPLICATED BY THE FACT THAT USERS WERE DESCRIBING MULTIPLE SYMPTOMS WHEN REPORTING THE COMPLAINTS. TO DATE, THE FREQUENCY OF WORLDWIDE REPORTED EVENTS FOR DIFFICULTIES REMOVING THE PROTECTIVE BALLOON SHEATH, INFLATION AND DEFLATION HAS REACHED AN ACTIONABLE LIMIT, THUS ABBOTT VASCULAR COMMUNICATED THE VOLUNTARY FIELD ACTION TO THE FDA [MEDWATCH # 2024168-2017-02310]. CORRECTIVE ACTION HAS BEEN IMPLEMENTED PER SITE OPERATING PROCEDURES. THE PRODUCT WILL CONTINUE TO BE TRENDED. THE ABBOTT INTERNAL RECALL NUMBER IS 2024168-3/14/2017-002-R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE PROTECTIVE SHEATH RESISTANCE WAS MET AND AFTER REMOVAL THE SHAFT WAS NOTED TO BE STRETCHED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757450 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 60824G1 08717648151880

    Patients

    Seq Age Sex Outcome Treatment
    1