BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 16230081 · Received January 23, 2023

    Report

    Report Number
    2024168-2023-00784
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    December 1, 2022
    Report Date
    January 23, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REPORTED INFORMATION, THE REPORTED PRESSUREWIRE DAMAGE/MATERIAL SEPARATION WAS LIKELY THE RESULT OF USING THE PRESSUREWIRE WITH THE SHOCKWAVE DEVICE. THE REPORTED UNEXPECTED MEDICAL INTERVENTION TO SNARE THE SEPARATED DISTAL SEGMENT OF THE WIRE WAS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PRESSUREWIRE X (PWX) WIRELESS WAS PLACED IN THE RAMUS AND IN THE LEFT ANTERIOR DESCENDING ARTERY AND SCHOCKWAVE WAS PERFORMED. THE PWX WAS DAMAGED AND THE PWX BROKE AFTER SCHOCKWAVE WAS PERFORMED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED DISTAL SEGMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569096 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention