BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2900339 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00135
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    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 MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, WIZZARD3. GUIDE CATH: AUTOBAHN, KIWAMI 4F. 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. 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 TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION AND 99% STENOSIS. DIFFICULTY ADVANCING THE NON-ABBOTT GUIDE WIRES WAS EXPERIENCED. THE LESION WAS FINALLY ACCESSED WITH A NON-ABBOTT GUIDE WIRE. THE 1.2 X 6 MM TREK RX BALLOON CATHETER WAS ADVANCED, BUT FAILED TO CROSS THE LESION. IT WAS ABLE TO CROSS THE LESION WITH THE SUPPORT OF A 4 FRENCH NON-ABBOTT MICROCATHETER. DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM) THE BALLOON RUPTURED. THE TREK BALLOON WAS RETRACTED AND WAS INFLATED OUTSIDE THE ANATOMY AND A PINHOLE RUPTURE WAS OBSERVED. THE LESION WAS FURTHER DILATED WITH A 1.0 X 5 MM NON-ABBOTT BALLOON CATHETER, THEN WITH A 2.5 X 12 MM TREK RX BALLOON CATHETER, AND A 2.5 X 23 MM XIENCE PRIME STENT WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7409 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20904G2

    Patients

    Seq Age Sex Outcome Treatment
    1