BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3073542 · Received April 23, 2013

    Report

    Report Number
    2024168-2013-02503
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT; GUIDE CATH: SHEATHLESS 6F JR 3.5. 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 REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. ROTOBLATION WAS PERFORMED AND THE 3.0 X 20 MM TREK BALLOON WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM) FOR PRE-DILATATION, AND FULLY DEFLATED. DURING REMOVAL, RESISTANCE WAS NOTED INSIDE THE GUIDING CATHETER AND THE BALLOON CATHETER SHAFT SEPARATED AT THE GUIDE WIRE EXIT NOTCH, INSIDE THE GUIDING CATHETER. THE DEVICES WERE REMOVED AS ONE UNIT WITH THE TWO PORTIONS OF THE TREK BALLOON CATHETER. A NEW GUIDING CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE WITH STENTING. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175287 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30109G1

    Patients

    Seq Age Sex Outcome Treatment
    1