BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2963921 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00890
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION AND KINK/ BEND WERE CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON 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 THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.0 X 12 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, IT COULD NOT CROSS. THE CATHETER WAS REMOVED AND A 1.5 X 12 MINI TREK BDC WAS ADVANCED AND IT CROSSED THE LESION AND WAS USED FOR PRE-DILATATION. THE 2.0 X 12 MM MINI TREK BDC WAS RE-INSERTED INTO THE ANATOMY AND IT STILL COULD NOT CROSS THE LESION. THE PROXIMAL SHAFT KINKED AND THEN SEPARATED OUTSIDE THE ANATOMY. THE SEPARATED PORTION WAS EASILY REMOVED. DILATATION WITH A 1.5 X 12 MM MINI TREK COMPLETED THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67436 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2032262

    Patients

    Seq Age Sex Outcome Treatment
    1