BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3031580 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01929
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND ANALYZED. THE REPORTED CATHETER SEPARATION WAS CONFIRMED ON THE RETURNED DEVICE AND MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A LESION IN THE CIRCUMFLEX (CX) ARTERY. THE 2.5 X 12 MM TREK BALLOON CATHETER WAS ADVANCED WITHOUT ISSUE TO THE LAD AND PRE-DILATATION WAS PERFORMED SUCCESSFULLY. THE TREK BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. THE LAD LESION WAS THEN STENTED. THE SAME TREK BALLOON CATHETER WAS THEN BEING PREPARED TO BE ADVANCED TO THE CX LESION; HOWEVER, DURING WIPE DOWN, THE PROXIMAL SHAFT SEPARATED. THE DEVICE WAS NO LONGER USED AND A NEW TREK BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134953 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21220G1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR