BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2810439 · Received October 31, 2012

    Report

    Report Number
    2024168-2012-06873
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 AND THE REPORTED RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, A 2.5 X 12 RX TREK DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE AND ATTEMPTED TO BE INFLATED AT 6 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT HOLD PRESSURE. REPORTEDLY, THE SITE SUSPECTED A BALLOON RUPTURE OCCURRED. THE 2.5 X 12 RX TREK DILATATION CATHETER WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT RESISTANCE AND A NEW SAME SIZE RX TREK DILATATION CATHETER WAS SUCCESSFULLY USED FOR PRE-DILATATION. AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1061761

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR