BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4093375 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05956
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION AND WINGED BALLOON WAS CONFIRMED. THE REPORTED DIFFICULT TO REMOVE THE BALLOON CATHETER WAS NOT CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A BRACHIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE ECCENTRIC, 70% RESTENOSED, NON-TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY PREDILATATION WITH A 5.0 X 10 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS COMPLETED AT 6 ATMOSPHERE (ATM) FOR 6 SECONDS AND INFLATED AGAIN. THE BDC WAS REMOVED AND THE 4.0 X 18 MM XIENCE PRIME STENT WAS DEPLOYED AT 14 ATM FOR 30 SECONDS. IT WAS NOTED THAT POST-DILATATION WAS COMPLETED USING A 5.0 X 15 MM NC TREK BDC AT 12 ATM AND 16 ATM BUT AFTER DEFLATION THE BDC MET RESISTANCE WHILE ATTEMPTING TO BE REMOVED. THE BDC WAS INFLATED AND DEFLATED TWICE AND WAS REMOVED WITH RESISTANCE. ALTHOUGH THE INDEFLATOR WAS NOT ON NEGATIVE PRESSURE, AFTER REMOVAL FROM THE ANATOMY THE BALLOON WAS NOTED TO BE WINGED. ADDITIONALLY, THE BDC SHAFT WAS NOTED TO HAVE SEPARATED DURING REMOVAL. 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
    571248 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40602G1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR STENT: XIENCE PRIME 4.0X18MM