BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3092331 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02753
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION DIFFICULTY WAS 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. 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.

    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 DURING A RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, VIA A FEMORAL ARTERY ACCESS, A 6 FRENCH NON-ABBOTT GUIDING CATHETER WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE. A FILTER WIRE WAS INSERTED TO THE LESION. TWO XIENCE PRIME STENTS WERE IMPLANTED SUCCESSFULLY AND A NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR ROUTINE POST-DILATATION WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED FOUR TIMES TO 16-18 ATMOSPHERES FOR ROUTINE PROXIMAL TO DISTAL POST-DILATATION AND FULLY DEFLATED PRIOR TO REMOVAL, BUT DURING REMOVAL AS THE NC TREK WAS BEING PULLED THROUGH THE GUIDING CATHETER, THE NC TREK BALLOON APPEARED TO "MUSHROOM" IN APPEARANCE AND THE BALLOON WOULD NOT PULL THROUGH THE GUIDING CATHETER. THE GUIDE WIRE, FILTER WIRE, NON-ABBOTT GUIDING CATHETER AND THE NC TREK WERE REMOVED AS ONE UNIT PER THE INSTRUCTIONS FOR USE WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. QUALITY RECEIVED THE DEVICE WITH THE HYPOTUBE SEPARATED AT THE DISTAL END. THE ACCOUNT WAS NOT AWARE OF THE SEPARATION AND DOES NOT KNOW WHEN THE SEPARATION OCCURRED. IT IS UNCLEAR IF THE SEPARATION OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194423 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30125G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: 6 FRENCH CORDIS