BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3033606 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01949
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION WAS 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 AND SCANNING ELECTRON MICROSCOPY ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. 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 MILDLY TORTUOUS, HEAVILY CALCIFIED, AND 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. THE PROXIMAL SHAFT OF THE 25X12 MM TREK BALLOON CATHETER FRACTURED IN TWO PIECES DURING A FAILED ATTEMPT TO CROSS. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NEW TREK BALLOON WAS USED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION RECEIVED AS FOLLOWS: THE BALLOON CATHETER HAD BEEN USED PREVIOUSLY FOR INFLATION PRIOR TO THE FAILED ATTEMPT TO RECROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136199 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20719G3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR