BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2800426 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06651
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION; GUIDE CATH: HEARTRAIL IL3.5. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 99% STENOSED LESION IN AN UN-SPECIFIED CORONARY ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. THE 2.5 X 15 MM TREK BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE AND ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION OF 8 ATMOSPHERES. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR REMOVAL. A NON-ABBOTT BALLOON WAS USED, BUT DID NOT EXPAND SUFFICIENTLY; THEREFORE, ROTOBLATION WAS PERFORMED. A XIENCE PRIME STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO 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 20716G2

    Patients

    Seq Age Sex Outcome Treatment
    1