BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4533134 · Received February 20, 2015

    Report

    Report Number
    2024168-2015-00924
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 9, 2015
    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).DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, ROTA WIRE, GRANDSLAM, GUIDE CATH: HYPERION 6F AL1, BAR1.5, FINECROSS GT. 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/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 DURING A PROCEDURE TO TREAT A DE NOVO, ECCENTRIC LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY, HEAVY CALCIFICATION AND 99% STENOSIS. A 1.20X6 MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT. THE BDC WAS INFLATED FOR THE FIRST TIME WHEN IT RUPTURED AT 4 ATMOSPHERES. THE BDC WAS REPORTED TO BE REMOVED FROM THE PATIENT ANATOMY WITHOUT ANY RESISTANCE. A NON-ABBOTT ROTATIONAL ATHERECTOMY DEVICE WAS USED. AN UNSPECIFIED LARGER BDC WAS THEN USED TO FURTHER DILATE THE LESION TO ULTIMATELY DEPLOY A XIENCE XPEDITION STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122944 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30310G1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR