BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2020761 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01776
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED RUPTURE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN AN UNSPECIFIED, NON-CALCIFIED VESSEL, THE TREK BALLOON RUPTURED AT 10 ATMOSPHERES. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1