BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3140717 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03424
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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 LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE BALANCE MIDDLEWEIGHT GUIDE WIRE REFERENCED IS BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT GROIN ACCESS APPROACH DURING A PROCEDURE OF THE RIGHT CORONARY ARTERY (RCA) THE OTW TREK AND A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WERE USED IN THE PROCEDURE AND AFTER UNSPECIFIED INFLATION RESISTANCE WAS MET DURING THE RETRACTION ATTEMPT AND THE DEAN VICES WERE REMOVED AS A SYSTEM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. IT WAS NOTED THAT SLIGHT RESISTANCE WAS FELT DURING ADVANCING BUT THE DEVICES BECAME STUCK AFTER INFLATION AND COULD NOT BE REMOVED SEPARATELY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT GUIDE WIRE AND BALLOON WITHOUT ISSUE. 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
    241905 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1