BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2923115 · Received January 18, 2013

    Report

    Report Number
    2024168-2013-00341
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    September 18, 2012
    Report Date
    December 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED AS (B)(6) 2012 BASED ON DATE OF (B)(4) REPORT (B)(4) 2012). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WAS NOT PROVIDED AND THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PHYSICIAN WAS ADVANCING THE NC TREK BALLOON CATHETER OVER AN UNKNOWN GUIDE WIRE, THE BALLOON CATHETER SHAFT BROKE PRIOR TO ENTERING THE SHEATH IN THE PATIENT. THE BALLOON CATHETER AND GUIDE WIRE WERE REMOVED, AND A NEW NC TREK WAS USED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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
    28084 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1