BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3170358 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03727
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION WAS CONFIRMED. THE INFLATION ISSUE COULD NOT BE TESTING DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL ANALYSIS 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE RX TREK INSTRUCTION FOR USE (IFU) STATES: IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE UNSPECIFIED VESSEL WITH A SOFT LESION, THE 3.0 X 15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR PRE-DILATATION. THE BDC WAS CONNECTED TO THE INDEFLATOR AND INFLATED BUT COULD NOT HOLD PRESSURE. THE DEVICE WAS REPLACED. A DIFFERENT NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED: DURING REMOVAL OF THE STIFF METAL WIRE [STYLET] BEFORE INTRODUCING BALLOON IN THE CORONARY ARTERY THE HYPOTUBE SEPARATED. ADDITIONALLY IT WAS NOTED THAT FORCE WAS USED WHICH MAY HAVE CONTRIBUTED TO THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271127 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30305G1

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION: INDEFLATOR