BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3243644 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04628
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION DIFFICULTY COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED. 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 THE REPORTED EVENT. 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. THE XIENCE EXPEDITION REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, HEAVILY TORTUOUS, RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, A TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT DIFFICULTY TO THE LESION FOR PRE-DILATATION. THE BALLOON WAS INFLATED AND THERE WAS DIFFICULTY DEFLATING THE BALLOON. THE BALLOON AND CATHETER WERE REMOVED WITH THE BALLOON FULLY INFLATED (DIFFICULTY TO REMOVE) AND UPON REMOVAL FROM THE PATIENTS ANATOMY, THE TIP OF THE BDC WAS FOUND INSIDE THE GUIDE CATHETER (SEPARATED). A XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE XIENCE XPEDITION BALLOON WOULD NOT INFLATE TO DEPLOY THE STENT. REPORTEDLY, THE PHYSICIAN BELIEVES THE BALLOON WOULD NOT INFLATE BECAUSE OF THE PATIENTS HEAVILY CALCIFIED ANATOMY. THE XIENCE XPEDITION SDS WAS REMOVED WITHOUT ISSUE AND THE LESION WAS DILATED AGAIN WITH ANOTHER TREK 4.0 X 20 MM BALLOON. ANOTHER XIENCE XPEDITION WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ISSUES NOTED WITH PREPARATION OF EITHER THE TREK RX BDC OR THE XIENCE XPEDITION SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR NO ADVERSE PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343719 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30125G1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR