BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2950514 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00752
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON RUPTURE COULD NOT BE CONFIRMED. BASED ON THE RETURNED DEVICE ANALYSIS A LEAK WAS IDENTIFIED DURING NEGATIVE PRESSURE. THE REPORTED DIFFICULTY TO REMOVE 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, A 3.5 X 15 RX TREK DILATATION CATHETER WAS ADVANCED AND NO RESISTANCE WAS NOTED. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED IMMEDIATELY ON THE FIRST INFLATION. THE BALLOON WAS ATTEMPTED TO BE INFLATED UP TO 8 ATMOSPHERES (ATMS) BUT THE BALLOON RUPTURED BEFORE REACHING 8 ATMS. THE 3.5 X 15 RX TREK DILATATION CATHETER WAS WITHDRAWN WITH SLIGHT RESISTANCE FROM THE PATIENT ANATOMY AND THE LESION WAS FURTHER DILATED WITH A NON-ABBOTT DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54803 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21011G1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR