BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 21402586 · Received February 18, 2025

    Report

    Report Number
    2024168-2025-01811
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DXO
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED STRETCHING AND DEFORMATION DUE TO COMPRESSIVE STRESS (BEND/KINK) WERE ABLE TO BE VISUALLY CONFIRMED; HOWEVER, THE REPORTED DIFFICULTY TO REMOVE AND FAILURE TO ADVANCE WERE NOT ABLE TO BE CONFIRMED DUE TO THE OPERATIONAL CONTEXT OF THE REPORTED ISSUES. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE, DEFORMATION DUE TO COMPRESSIVE STRESS, STRETCHING, AND DIFFICULTY TO REMOVE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS NOTED TO BE KINKED AND BENT THROUGHOUT, AND THE DISTAL TIP COIL WAS STRETCHED, WHICH ARE BOTH CONSISTENT WITH THE REPORTED DAMAGE AND WITH CAUSING, CONTRIBUTING, OR BEING CAUSE BY THE FAILURE TO ADVANCE AND DIFFICULTY TO REMOVE. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE TECHNIQUES EMPLOYED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: D3 - MFG ESTABLISHMENT NAME: UPDATED FROM LIGHTLAB IMAGING, INC. TO ST. JUDE MEDICAL, INC. D3 - ADDRESS 1: UPDATED FROM 4 ROBBINS RD. TO 5050 NATHAN LANE NORTH D3 - CITY: UPDATED FROM WESTFORD TO PLYMOUTH D3 - REGION STATE: UPDATED FROM MA TO MN D3 - POSTAL CODE: UPDATED FROM 01886 TO 55442 D4 - LOT # : UPDATED FROM 40920G1 TO 40904G1 D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). G1 - MFG SITE ESTABLISHMENT NAME: UPDATED FROM ABBOTT VASCULAR, REG # 2024168 TO ABBOTT VASCULAR COSTA RICA, REG # 3009564766. G1 - MFG SITE ADDRESS 1: UPDATED FROM 26531 YNEZ ROAD TO 52 CALLE 3 B31 COYOL FREE ZONE G1 - MFG SITE CITY: UPDATED FROM TEMECULA TO EL COYOL ALAJUELA G1 - MFG SITE REGION (STATE): UPDATED FROM CA TO NA G1 - MFG SITE POSTAL CODE: UPDATED FROM 92591-4628 TO UNK G1 - MFG SITE COUNTRY: UPDATED FROM USA TO CRI H4 - DEVICE MFG DATE: UPDATED FROM 9/20/2024 TO 9/4/2024.

    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 THE PRESSUREWIRE X WIRELESS (PWX) DID NOT CROSS THE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DUE TO CHALLENGING ANATOMY. THE DEVICE MET RESISTANCE WITH THE PATIENT ANATOMY AND GOT STUCK IN THE DISTAL LAD DURING REMOVAL. SUBSEQUENTLY, IT WAS NOTED THAT DISTAL TIP OF THE DEVICE BECAME BENT AND ELONGATED WHEN THE DEVICE WAS REMOVED. A NEW PWX WAS USED INSTEAD TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572793 PRESSUREWIRE¿ CATHETER TIP PRESSURE TRANSDUCER DXO ST. JUDE MEDICAL, INC. C12059 40904G1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown