BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 8092819 · Received November 20, 2018

    Report

    Report Number
    2024168-2018-08989
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 17, 2018
    Report Date
    December 5, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). DEVICE EVALUATED BY MFR CORRECTION: DEVICE STATUS CHANGED FROM NOT RETURNED TO RETURNED. CORRECTION - REMOVED METHOD CODE 4115, REMOVED RESULT CODE 3221, REMOVED CONCLUSION CODE 67. EVALUATION SUMMARY: VISUAL, FUNCTIONAL AND SEM INSPECTIONS/ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED LEAK WAS CONFIRMED. THE BALLOON WAS ULTIMATELY SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. THE SEM REPORT DETERMINED THE INNER MEMBER LEAK MAY BE ATTRIBUTED TO A MATERIAL/PROCESSING DISCREPANCY AND/OR EXPOSURE CONDITIONS. THE LONGITUDINAL LEAK WAS FOUND APPROXIMATELY 3.2CM PROXIMAL TO THE PROXIMAL MARKER. MATERIAL TEARING/SPLITTING WAS DOCUMENTED AT THE LEAK EDGES ON BOTH ID AND OD SURFACES. NO SIGNIFICANT MECHANICAL DAMAGE ASSOCIATED WITH THE FAILURE MECHANISM WAS OBSERVED. THE INVESTIGATION DETERMINED THE REPORTED LEAK APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: DEVICE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IN THE ABSENCE OF DEVICE RETURNED FOR ANALYSIS A CONCLUSIVE CAUSE FOR THE REPORTED LEAK COULD NOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE IN THE ANATOMY, BUBBLES WERE OBSERVED IN THE 1.5 X 12 MM MINITREK BALLOON DURING ASPIRATION. THERE WAS NO PATIENT INVOLVED. THE DEVICE WAS NOT USED; A 1.5 X 8 MM MINI TREK WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929848 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80305G1

    Patients

    Seq Age Sex Outcome Treatment
    1