BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3222589 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04324
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE REPORTED RESISTANCE COULD NOT BE CONFIRMED DUE TO DEVICE CONDITION AND THE GUIDING CATHETER WAS NOT RETURNED. THE CAUSE OF THE REPORTED RESISTANCE COULD NOT BE DETERMINED. THE REPORTED SHAFT SEPARATION WAS CONFIRMED ON THE RETURNED DEVICE AND MOST LIKELY DUE TO HANDLING DURING CATHETER ADVANCEMENT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON ALL THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS (B)(6) 2013. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UN-SPECIFIED PROCEDURE, THE 3.0 X 12 MM NC TREK BALLOON CATHETER WAS UNPACKAGED WITHOUT ISSUE AND ADVANCED INTO THE GUIDING CATHETER; HOWEVER, RESISTANCE WAS NOTED WITH THE GUIDING CATHETER AND THE SHAFT SEPARATED PRIOR TO REACHING THE TARGET LESION. THE DEVICE WAS REMOVED WITHOUT ISSUE. A NEW NC TREK BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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
    324299 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21004G1

    Patients

    Seq Age Sex Outcome Treatment
    1