BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4232915 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07264
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 14, 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: ABBOTT ANALYZED THE RETURNED DEVICE AND CONFIRMED THE DIFFICULTY TO REMOVE THE BALLOON SHEATH. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO SIMILAR INCIDENTS FROM THIS LOT. ABBOTT CONDUCTED ROOT CAUSE ANALYSIS AND DURING FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA FOUND THE OCCURRENCE TO BE POTENTIALLY RELATED TO A MANUFACTURING ISSUE. ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED, CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN IMPLEMENTED PER INTERNAL QUALITY SYSTEM PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND PRIOR TO USE THE 3.5 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) PROTECTIVE SHEATH COULD NOT BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT; THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713096 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 3012361

    Patients

    Seq Age Sex Outcome Treatment
    1