BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3053528 · Received April 11, 2013

    Report

    Report Number
    2024168-2013-02204
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    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. GUIDE CATHETER: HEARTRAIL JL4.0. STENT: 3.5X23 RX XIENCE PRIME. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION DIFFICULTY WAS CONFIRMED DUE TO THE CONDITION OF THE DEVICE. BASED ON VISUAL AND FUNCTIONAL 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 THE PROCEDURE, AFTER IMPLANTING A 3.5X23 RX XIENCE PRIME STENT IN A NON-CALCIFIED, CONCENTRIC, 20-MILLIMETER-LONG 75% STENOSED, DE NOVO LESION IN THE 4-MILLIMETER-DIAMETER NON-TORTUOUS LEFT MAIN CORONARY ARTERY, A 4.5X8 NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO PERFORM ROUTINE POST-DILATATION OF THE STENT. THE NON-ABBOTT GUIDING CATHETER WAS MOVED BACK FROM THE AORTA SINCE THE STENT WAS IMPLANTED IN LEFT MAIN. WITH THE NC TREK RX POSITIONED IN THE STENT, AFTER INFLATING THE NC TREK RX A 3RD TIME TO 12 ATMOSPHERES FOR 20 SECONDS, THE BALLOON DID NOT COMPLETELY DEFLATE. AFTER A FAILED ATTEMPT TO RUPTURE THE BALLOON USING AN UNSPECIFIED GUIDE WIRE, THE HUB OF THE TREK DEVICE WAS INTENTIONALLY CUT BY THE PHYSICIAN. THEN AN UNSPECIFIED 5FR GUIDING CATHETER WAS CUT TO EXPOSE THE STAINLESS STEEL BRAIDED WIRES. THE GUIDE CATHETER SEGMENT WAS THEN ADVANCED OVER THE PROXIMAL END OF THE TREK AND USED TO INTENTIONALLY PRICK AND RUPTURE THE BALLOON, ENABLING REMOVAL OF THE NC TREK RX FROM THE ANATOMY WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT BDC. REPORTEDLY, THE NC TREK RX SHAFT MAY HAVE KINKED DURING INFLATION DUE TO THE POSITIONING OF THE GUIDING CATHETER, AS IT WAS NOT COAXIALLY POSITIONED WITH THE CORONARY. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155579 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2091161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention