BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2233576 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06141
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 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. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE 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. 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 ACCESSORY DEVICES, OR THE MILDLY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 8 ATMOSPHERE. A REVIEW OF THE DEVICE LOT HISTORY RECORD 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 REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A MILDLY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, DE NOVO, 100% CHRONIC TOTAL OCCLUSION STENOSIS OF THE RIGHT CORONARY ARTERY, THE 3.0 MM X 15 MM TREK WAS USED FOR PREDILATATION BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERE. A SECOND BALLOON AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0080961

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: MACH 1 AL