BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3112698 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03060
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY 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. IT SHOULD BE NOTED THAT THE RX MINI TREK/TREK INSTRUCTION FOR USE WARNS: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). IN THIS CASE, IT IS PROBABLE THAT THE LESION SITE OR STENT AND NOT THE OVER-INFLATION OF THE BALLOON CONTRIBUTED TO THE RUPTURE. OVERALL, THE BALLOON RUPTURE APPEARS TO BE DUE TO OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY VEIN GRAFT. A 4.0 X 20 MM TREK WAS BEING USED FOR POST-DILATATION AND PRESSURIZED TO 8 ATMOSPHERES FOR 20 SECONDS IN THE DISTAL PORTION OF THE IMPLANTED STENT, THEN IN THE PROXIMAL END OF THE STENT AT 17 ATMOSPHERES FOR 21 SECONDS WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND A SECOND 4.0 X 20 MM TREK WAS USED TO CONTINUE POST-DILATATION. THE BALLOON WAS INFLATED 10 TIMES AND IT WAS THEN ADVANCED DISTALLY; HOWEVER, IT COULD NOT MOVE FORWARD BECAUSE THE BALLOON WAS WINGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213169 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30108G1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR