BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2902396 · Received January 8, 2013

    Report

    Report Number
    2024168-2013-00157
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. CONCOMITANT MEDICAL DEVICE: GUIDE CATH: 8F VIKING GUIDING CATHETER. THE DEVICE WAS RETURNED FOR EVALUATION AND 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 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 DURING A CIRCUMFLEX ARTERY / OBTUSE MARGINAL BIFURCATION STENTING PROCEDURE, AFTER SUCCESSFULLY DEPLOYING 2 XIENCE V STENTS, A 2.0 X 12 MM AND A 2.75 X 15 MM TREK BALLOON DILATATION CATHETER WAS TAKEN TO EACH STENTED LESION. BOTH BALLOONS WERE SIMULTANEOUSLY INFLATED AND DEFLATED. SOME RESISTANCE WAS FELT DURING REMOVAL OF THE 2.0 X 12 MM MINI TREK BALLOON DILATATION CATHETER, BUT THEN IT WAS EASILY REMOVED. UPON REMOVAL, AND DURING THE FINAL ANGIOGRAM BALLOON MARKERS WERE SEEN IN THE LEFT MAIN ARTERY. AT THAT POINT IT WAS NOTED THAT APPROXIMATELY 15 MM OF THE TIP OF THE BALLOON DILATATION CATHETER WAS DETACHED FROM THE DEVICE. A 3.5 X 20 MM TREK DILATATION CATHETER WAS TAKEN BEYOND THE DETACHED PORTION OF THE 2.0 X 12 MM MINI TREK BALLOON DILATATION CATHETER AND SLOWLY INFLATED. THE 3.5 X 20 MM TREK BALLOON DILATATION CATHETER WAS SLOWLY BACKED UP, PULLING THE DETACHED PORTION AND THE INFLATED BALLOON INTO THE 8F GUIDING CATHETER. EVERYTHING WAS REMOVED AS A UNIT, SUCCESSFULLY REMOVING THE DETACHED PORTION OF THE 2.0 X 12 MM MINI TREK BALLOON DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9102 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20723G1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention