BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 5902200 · Received August 24, 2016

    Report

    Report Number
    2024168-2016-05672
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 12, 2016
    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). EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED RUPTURE WAS ABLE TO BE CONFIRMED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, GUIDE CATHETER: HYPERION JR4. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY TORTUOUS, 90% STENOSED RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE A 2.00 X 20 MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION AND ON THE FIRST INFLATION OF THE BDC TO 12 ATMOSPHERES THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NON-ABBOTT BALLOON CATHETER AND NON-ABBOTT STENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552922 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50928G1

    Patients

    Seq Age Sex Outcome Treatment
    1