BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3110093 · Received May 13, 2013

    Report

    Report Number
    2024168-2013-03020
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED INFLATION/DEFLATION DIFFICULTIES WERE NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY (CX) WITH HEAVY TORTUOSITY AND MODERATE CALCIFICATION. THE LESION WAS PRE-DILATED SUCCESSFULLY WITH THE 2.0 X 20 MM MINI TREK BALLOON. HOWEVER, INFLATION OF THE BALLOON WAS REPORTED TO BE SLIGHTLY SLOW. DURING DEFLATION OF THE BALLOON, IT COULD NOT BE COMPLETELY DEFLATED. THE PARTIALLY INFLATED BALLOON WAS RETRACTED FROM THE ANATOMY WITHOUT RESISTANCE. OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE HYPOTUBE WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNSPECIFIED STENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211555 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20721G1

    Patients

    Seq Age Sex Outcome Treatment
    1