BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2141678 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04501
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 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. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE ON THE SHAFT CONSISTENT WITH HANDLING. THERE WAS CONTRAST IN THE INFLATION LUMEN CONSISTENT WITH PREPARATION. THE BALLOON WAS LOOSELY FOLDED. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WHEN FLUID WAS OBSERVED LEAKING FROM A 2MM LONGITUDINAL RUPTURE IN THE MIDDLE OF THE BALLOON, CONFIRMING THE REPORTED RUPTURE. THERE WAS A LONGITUDINAL SCRATCH IN THE BALLOON DISTAL TO THE RUPTURE FOR A LENGTH OF 4MM. 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 THE RBP. 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 LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE MODERATELY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED AT THE RBP DURING SECOND INFLATION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RX TREK BALLOON CATHETER WAS USED TO PRE-DILATE THE MID LEFT ANTERIOR DESCENDING ARTERY. AFTER INFLATING THE CATHETER TO 14 ATMOSPHERES (ATM) FOR 15 SECONDS IT WAS NOTED THAT THE MODERATELY CALCIFIED LESION WAS NOT COMPLETELY EXPANDED. VESSEL AND LESION SITE WERE CHARACTERIZED AS BEING NON-TORTUOUS, CONCENTRIC, DE NOVO AND 90% STENOSED. THEREFORE THE TREK CATHETER WAS RE-DELIVERED BUT WAS ONLY ABLE TO INFLATE A SECOND TIME TO AROUND 3 TO 4 ATM DUE TO A BALLOON RUPTURE. THE RUPTURE WAS NOTED DUE TO CONTRAST LEAKING FROM THE BALLOON. A XIENCE V STENT WAS IMPLANTED AFTERWARDS TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 GUIDE WIRE: SION BLUEGUIDE CATH: LAUNCHER EBU 6F