BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 7733069 · Received July 30, 2018

    Report

    Report Number
    2024168-2018-05873
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 20, 2018
    Report Date
    July 30, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648138294
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: DIL CATH: IKAZUCHI , GUIDE WIRE: SION BLUE, XT-R, GAIA NEXT 1ST, GUIDE CATH: HYPERION, STENT: XIENCE XPEDITION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 100% STENOSED. DILATATION WAS PERFORMED USING A 2.5 X 15 MM RX TREK BALLOON CATHETER WHEN WAS RESISTANCE MET WITH THE LESION DURING ADVANCEMENT. THE BALLOON CATHETER CROSSED THE TARGET LESION AND WHEN THE BALLOON WAS INFLATED ONCE TO APPROXIMATELY 10 ATMOSPHERES, THE BALLOON RUPTURED. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE DILATATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED STENT. 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
    573322 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80205G3 08717648138294

    Patients

    Seq Age Sex Outcome Treatment
    1