BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 14254297 · Received April 29, 2022

    Report

    Report Number
    2024168-2022-04682
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648138225
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    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 AND/OR COMPLAINTS FROM THIS LOT.D4 - LOT NUMBER, D4 - CATALOG NO, D4 - UDI #, H4 - DEVICE MANUFACTURE DATE, H10 - ADDTL MFG NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT CORONARY ARTERY. THE 2.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL DILATATION WAS PERFORMED WITH AN NC TREK AND A XIENCE STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE LOT NUMBER WAS CONFIRMED TO BE 10422G2, NOT 10406G1. THE PART NUMBER WAS CONFIRMED TO BE 1012271-15, NOT 1012272-15. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438233 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012272-15 10422G2 08717648138225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown