BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 4122085 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06216
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE; GUIDE CATHETER: AUTOBAHN. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS OF BALLOON RUPTURE REPORTED FROM THIS LOT. 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 99% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND CALCIFICATION. THROMBOSIS WAS PRESENT AT THE BEGINNING OF THE PROCEDURE. THE 2.5 X 15 MM TREK BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE LESION FOR PRE-DILATATION SO THAT THROMBUS ASPIRATION COULD BE PERFORMED. DURING ADVANCEMENT OF THE TREK, RESISTANCE WAS MET WITH THE ANATOMY IN THE RIGHT CORONARY ARTERY. THE TREK WAS ABLE TO CROSS TO THE LESION, AND ATTEMPTED TO BE INFLATED TO AN UNKNOWN PRESSURE; HOWEVER, THE BALLOON DID NOT INFLATE AT ALL, AND WAS FOUND TO BE RUPTURED. A NON-ABBOTT BALLOON CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE AND THROMBOSIS ASPIRATION WAS PERFORMED. A STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETE. 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
    600358 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31001G1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR CONCOMITANT MEDICAL DEVICES