BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3715706 · Received March 31, 2014

    Report

    Report Number
    2024168-2014-01980
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: GUIDE WIRE: ELITE II. (B)(4) - USE AFTER DAMAGE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED CATHETER KINK/SEPARATION WAS CONFIRMED ON THE RETURN. THE CATHETER WAS LIKELY KINKED DUE TO ACCIDENTAL HANDLING DURING REMOVAL FROM THE DISPENSER COIL. THE SHAFT SEPARATED DUE TO ADVANCING THE KINKED SHAFT THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). BASED ON THE 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 THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE NC TREK INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USE EXAMINE ALL EQUIPMENT CAREFULLY FOR DEFECTS. EXAMINE THE DILATATION CATHETER FOR BENDS, KINKS OR OTHER DAMAGE. DO NOT USE IF THE PACKAGE IS OPEN OR DAMAGED. DO NOT USE ANY DEFECTIVE EQUIPMENT. BASED ON ALL THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND REMOVAL FROM THE PROTECTIVE COIL RESISTANCE WAS MET AND THE PROXIMAL SHAFT 5-10 CM DISTAL TO THE HUB WAS FOUND TO BE KINKED/BENT. THE 3.5 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND DURING ADVANCING INTO THE ROTATING HEMOSTASIS VALVE (RHV) THE PROXIMAL SHAFT SEPARATED. THE DEVICE WAS REMOVED AND WAS NOT USED. A 3.5 X 15 MM NON-ABBOTT BDC WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191211 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30912G1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR