BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2131830 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04272
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE (RBP). RETURN OF THE RX TREK CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE MODERATELY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 8ATM WHICH IS BELOW THE RATED BURST PRESSURE (RBP). A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR BALLOON RUPTURE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS A DIFFUSE LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A 2.0 X 20 MM TREK. THEN THE 2.5 X 15 MM TREK WAS DELIVERED NEXT FOR ADDITIONAL PRE-DILATATION. DURING THE FIRST INFLATION, THE 2.5 X 15 MM TREK BALLOON RUPTURED AT 8 ATMOSPHERES. A PINHOLE WAS OBSERVED IN THE BALLOON. IT WAS REPLACED WITH A 3.0 X 20 MM TREK AND FOUR XIENCE STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 0083062

    Patients

    Seq Age Sex Outcome Treatment
    1