BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2800095 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06641
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 DURING A CORONARY PROCEDURE, THE PROXIMAL SHAFT OF THE TREK SEPARATED OUTSIDE THE ANATOMY PRIOR TO REACHING THE TARGET LESION IN THE DISTAL RIGHT CORONARY ARTERY. REPORTEDLY, THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT. THE TREK WAS REMOVED FROM THE ANATOMY. A SECOND TREK WAS USED TO COMPLETE THE PROCEDURE USING THE SAME GUIDEWIRE AND GUIDE CATHETER WITHOUT FURTHER INCIDENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20326G1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR