BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3061376 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02319
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED BALLOON SLIPPAGE WAS NOT CONFIRMED AS IT MAY HAVE BEEN RELATED TO ANATOMICAL CONDITIONS WHICH COULD NOT BE REPLICATED. BASED ON VISUAL 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. 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). 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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.5X15 MM TREK BALLOON CATHETER SLIPPED IN THE LESION WHEN INFLATED TO NOMINAL PRESSURE, ONLY INFLATING THE PROXIMAL END. A SECOND ATTEMPT WAS MADE TO INFLATE THE BALLOON TO NOMINAL AND IT DID THE SAME THING, THIS TIME INFLATING THE DISTAL END. AFTER THE THIRD ATTEMPT, WHICH DID NOT EVEN REACH NOMINAL, THE BALLOON SLIPPED AGAIN. AS THIS SAME ISSUE HAD OCCURRED DURING A PREVIOUS EVENT, THE DECISION WAS MADE TO REMOVE THE BALLOON. A NON-ABBOTT BALLOON CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162357 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20913G2

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR