BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK

    MDR report key: 20975762 · Received December 19, 2024

    Report

    Report Number
    2024168-2024-15019
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 2, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648138447
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED COMPLAINT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. ALL CURRENTLY AVAILABLE EVIDENCE POINTS TO THE PLACEMENT OF THE NC TREK NEO 3.0MM X 20MM IN THE CHIPBOARD BOX FOR A TREK 3.0MM X 20MM HAVING OCCURRED AT THE HOSPITAL. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE AS THE RESPECTIVE LOTS WERE MANUFACTURED APPROXIMATELY SIX MONTHS APART AND ON TWO DIFFERENT MANUFACTURING LINES WHICH INDICATES THE TWO UNITS INVOLVED IN THIS COMPLAINT NEVER CAME INTO CONTACT WITH ONE ANOTHER DURING PRODUCTION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) (PART 1012274-20 LOT 40417G1); HOWEVER IT WAS NOTED THAT THE DEVICE WITHIN THE PACKAGE DID NOT MATCH WHAT WAS LABELED ON THE BOX. THE DEVICE WITHIN THE PACKAGE WAS NOTED TO BE A 3.0X20MM NC TREK NEO (PART 1400300-20 / LOT 31007G1) INSTEAD OF A NC TREK. ANOTHER NC TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO FILING THE INITIAL REPORT, UPDATE TO THE EVENT DESCRIPTION CHANGING NC TREK TO TREK: IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM TREK BALLOON DILATATION CATHETER (BDC) (PART 1012274-20 LOT 40417G1); HOWEVER, IT WAS NOTED THAT THE DEVICE WITHIN THE PACKAGE DID NOT MATCH WHAT WAS LABELED ON THE BOX. THE DEVICE WITHIN THE PACKAGE WAS NOTED TO BE A 3.0X20MM NC TREK NEO (PART 1400300-20 / LOT 31007G1) INSTEAD OF A TREK. ANOTHER TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) (PART 1012274-20 LOT 40417G1); HOWEVER IT WAS NOTED THAT THE DEVICE WITHIN THE PACKAGE DID NOT MATCH WHAT WAS LABELED ON THE BOX. THE DEVICE WITHIN THE PACKAGE WAS NOTED TO BE A 3.0X20MM NC TREK NEO (PART 1400300-20 / LOT 31007G1) INSTEAD OF A NC TREK. ANOTHER NC TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088274 TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1012274-20 40417G1 08717648138447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown