BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 7894483 · Received September 20, 2018

    Report

    Report Number
    2024168-2018-07299
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 20, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE, XT-R, GAIA NEXT 1, 2, UB3; GUIDE CATH: HYPERION AL 1.0 7F, HYPERION SPB 3.5 8F, IVUS (VOLCANO). THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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 REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONAL MANIPULATION AND/OR INADVERTENT MISHANDLING OF THE DEVICE DURING ADVANCEMENT AGAINST RESISTANCE LIKELY COMPROMISED OR DAMAGED THE BALLOON RESULTING IN THE REPORTED BALLOON RUPTURE DURING THE SECOND INFLATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED, MILDLY TORTUOUS CHRONIC TOTALLY OCCLUDED, AND MILDLY CALCIFIED CONCENTRIC DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT DEVICE, A 2.5 X 15 MM TREK RX BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON OF THE BDC RUPTURED AT APPROXIMATELY 14 ATMOSPHERES DURING ITS SECOND INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED BDC. 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
    733788 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80528G2 08717648138294

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR