BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4090628 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05933
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED DEVICE ANALYSIS WAS UNABLE TO CONFIRM THE DIFFICULTY REMOVING THE PROTECTIVE BALLOON SHEATH, AS THE SHEATH WAS NOT RETURNED. A SEARCH OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND TWO OTHER INCIDENTS WERE IDENTIFIED FROM THIS LOT FOR SHEATH REMOVAL ISSUES. WHILE A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO DIFFICULTIES REMOVING THE BALLOON PROTECTIVE SHEATH WAS IDENTIFIED. THE EVENT WAS POSSIBLY RELATED TO A MANUFACTURING ISSUE. CORRECTIVE AND PREVENTATIVE ACTIONS WERE IMPLEMENTED. THESE DEVICES WILL CONTINUE TO BE MONITORED.

    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 UNPACKAGING OF THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC), THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE AND THE BDC BECAME DAMAGED, THUS THE BDC WAS NOT USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, THE BDC WAS RETURNED WITH THE DISTAL SHAFT (INNERMEMBER) SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569947 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 3052461

    Patients

    Seq Age Sex Outcome Treatment
    1