BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4243457 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07331
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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. THE HI-TORQUE WHISPER GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. 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 DIFFICULT TO REMOVE WITH THE GUIDE WIRE INCIDENTS REPORTED FOR 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 DURING A PROCEDURE TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM) WITH HEAVY TORTUOSITY, A 2.0X12 OTW MINI TREK DILATATION CATHETER AND A 2.0X15 OTW MINI TREK DILATATION CATHETER WERE BOTH USED MULTIPLE TIMES FOR DILATATION DURING THE PROCEDURE. THE 2.0X15 OTW MINI TREK DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE AND A COUPLE OF INFLATIONS WERE PERFORMED AND THE BALLOON WAS DEFLATED. DURING REMOVAL OF THE 2.0X15 OTW MINI TREK DILATATION CATHETER RESISTANCE WAS FELT WITH A WHISPER MS GUIDE WIRE. THE WHISPER MS GUIDE WIRE COULD NOT BE REMOVED FROM THE 2.0X15 OTW MINI TREK DILATATION CATHETER SO BOTH DEVICES WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND A NON-ABBOTT STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE NON-ABBOTT STENT WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED AND A 2.5X12 MM NON-ABBOTT STENT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726319 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31128G1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR GUIDE WIRE: WHISPER MS