BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2880099 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08167
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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 MILDLY TORTUOUS, HEAVILY CALCIFIED, AND CONCENTRIC MID LEFT ANTERIOR DESCENDING ARTERY. AN UNKNOWN GUIDE WIRE WAS USED TO CROSS THE LESION USING RETROGRADE APPROACH. THE GUIDE WIRE WAS THEN REPLACED WITH A NON-ABBOTT GUIDE WIRE AND A 1.5 X 15 MM MINI TREK BALLOON CATHETER WAS ADVANCED ANTEGRADE APPROACH. AN ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON CATHETER; HOWEVER, THE PRESSURE ON THE NON-ABBOTT INFLATION DEVICE DID NOT INCREASE. THE CONNECTION OF THE CATHETER AND INFLATION DEVICE WAS CHECKED TO SEE IF IT WAS LOOSE, BUT THERE WAS DIFFICULTY DISCONNECTING THE TWO DEVICES. FORCE WAS APPLIED AND THE HUB OF THE CATHETER DETACHED FROM THE SHAFT. THE PROCEDURE WAS CONTINUED USING A NEW TREK BALLOON CATHETER WITH THE SAME INFLATION DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20716G1

    Patients

    Seq Age Sex Outcome Treatment
    1