BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3243040 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04610
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SUBSEQUENT TO THE INITIAL FILED REPORT, IT WAS NOTED THAT THE PROCEDURE TOOK PLACE IN AN UNSPECIFIED CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE POST-DILATATION OF AN IMPLANTED 3.5X28 RX XIENCE XPEDITION STENT WITH A 4.0X15 NC TREK RX BALLOON DILATATION CATHETER (BDC) VIA ONE INFLATION TO A PRESSURE OF ABOUT 16 ATMS VIA RADIAL ACCESS, THE NC TREK RX BALLOON WAS UNABLE TO BE DEFLATED, DESPITE MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON BY DRAWING NEGATIVE AND HOLDING IT AND THEN TRYING TO INFLATE AGAIN AND DEFLATE. AFTER APPROXIMATELY TWO MINUTES OF THE BALLOON REMAINING INFLATED IN THE VESSEL, THE PATIENT BEGAN TO EXPERIENCE CHEST DISCOMFORT. WHILE RETRACTING THE STILL INFLATED BALLOON INTO THE GUIDING CATHETER AGAINST RESISTANCE, THE BALLOON DEFLATED ENOUGH TO BE RETRACTED THROUGH THE GUIDE CATHETER, WITH THE GUIDE CATHETER AND GUIDE WIRE REMAINING IN POSITION. THE ROUTINE STENT POST-DILATATION WAS COMPLETED USING ANOTHER 4.0X15 NC TREK RX BDC WITH NO FURTHER COMPLICATIONS. THE CHEST DISCOMFORT RESOLVED ON ITS OWN ONCE THE BALLOON WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342812 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30304G1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other STENT: 3.5 X 28MM XPEDITION