BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6156400 · Received December 8, 2016

    Report

    Report Number
    2024168-2016-08709
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 16, 2016
    Report Date
    April 3, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE RETURNED FOR ANALYSIS. THE COMPLAINT INVESTIGATION DETERMINED THE REPORTED DIFFICULTY WAS 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 ON MARCH 17, 2017 [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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5 X 12 MM NC TREK BALLOON CATHETER, IT WAS VERY DIFFICULT TO REMOVE THE PROTECTIVE SHEATH FROM THE DEVICE. THE DEVICE WAS NOT USED FOR THE PROCEDURE. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807338 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 60601G1

    Patients

    Seq Age Sex Outcome Treatment
    1