BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 1785442 · Received August 2, 2010

    Report

    Report Number
    2024168-2010-01565
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFLATION ABOVE RATED BURST PRESSURE. THE TREK 2.0 X 15 (PART 1012270-15, LOT 0050761), TREK 2.5 X 15 (PART 1012272-15, LOT 0042961) AND TREK 2.75 X 12 (PART 1012273-12 LOT 0041461) ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING THE COMPLEX PROCEDURE IN THE OSTIUM OF THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, FOUR TREK DILATATION CATHETERS WERE USED TO PRE-DILATED THE LESION. ALL FOUR BALLOONS RUPTURED WHEN INFLATED ABOVE THE RATED BURST PRESSURE. FOUR NON-ABBOTT DILATATION CATHETERS WERE USED AND ALSO RUPTURED. REPORTEDLY, THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR - CARDIAC THERAPIES NA 0042961

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: TSUNAMI| TREK 2.75 X 12 (PART 1012273-12, LOT 0041461)| TREK 2.5 X 15 (PART 1012272-15, LOT 0042961)| TREK 2.0 X 15 (PART 1012270-15, LOT 0050761)