BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3073283 · Received April 23, 2013

    Report

    Report Number
    2024168-2013-02496
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DIFFICULTIES WERE CONFIRMED. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 THE TARGET LESION WAS A RESTENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 4.0 X 12 MM NC TREK BALLOON WAS ADVANCED FOR PRE-DILATATION. IT WAS INFLATED TO 8 ATMOSPHERES (ATM) FOR 20 SECONDS, THEN INFLATED TO 10 ATM FOR 15 SECONDS, THEN IT WAS INFLATED TO 14 ATM FOR 10 SECONDS FOR A TOTAL OF 3 INFLATIONS. THEN THE BALLOON WAS INFLATED TO 12 ATM FOR 12 SECONDS AND THEN INFLATED TO 16 ATM FOR 10 SECONDS. THE NC TREK BALLOON WAS RETRACTED; HOWEVER, UPON REACHING THE NON-ABBOTT GUIDE CATHETER, THE BALLOON COULD NOT BE RETRACTED INTO THE GUIDING CATHETER. THE BALLOON WAS INFLATED TO 2 ATM, THEN NEGATIVE WAS PULLED. HOWEVER, THE BALLOON STILL COULD NOT BE RETRACTED. IT WAS REMOVED AS A UNIT WITH THE GUIDING CATHETER. UPON REMOVAL FROM THE ANATOMY, THE BALLOON WAS NOTED TO HAVE POOR REFOLD. SEVERAL OTHER NON-ABBOTT BALLOONS AND STENTS WERE ATTEMPTED, HOWEVER, NONE WERE ABLE TO CROSS. A BUDDY WIRE WAS THEN ADVANCED AND A NON-ABBOTT STENT WAS ABLE TO CROSS AND WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175124 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30219G1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR GUIDE CATH: 6 FRENCH AL1