BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4141245 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06441
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II; GUIDE CATH: MEDTRONIC LAUNCHER, EBU 6F. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED RESISTANCE WITH THE GUIDE WIRE WAS CONFIRMED. THE DIFFICULT TO REMOVE WAS NOT TESTED DUE TO THE STRETCHED SHAFT. BASED ON VISUAL, DIMENSIONAL 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO POSITION WITH THE GUIDE WIRE OR DIFFICULT TO REMOVE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE UNSPECIFIED CORONARY VESSEL THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE AND A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WERE USED FOR PRE-DILATATION AND A 3.5 X 38 MM AND A 3.5 X 28 MM XIENCE XPEDITION STENTS WERE IMPLANTED. THE 4.0 X 15 MM NC TREK BDC WAS ATTEMPTED FOR POST-DILATATION. THE PROTECTIVE SHEATH WAS REMOVED AND THE BDC WAS INSERTED ONTO THE PROXIMAL END OF THE GUIDE WIRE OUTSIDE THE ANATOMY; HOWEVER, THE TIP OF THE BDC MET RESISTANCE AND BECAME STUCK. THE BDC WAS NOT INSERTED INTO THE ANATOMY AND WAS REMOVED FROM THE GUIDE WIRE. USING THE SAME GUIDE WIRE IN THE ANATOMY A 4.0 X 12 MM NC TREK BDC WAS USED SUCCESSFULLY FOR POST-DILATATION WITHOUT REPORTED ISSUE. 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
    619754 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30122G1

    Patients

    Seq Age Sex Outcome Treatment
    1