BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 23203367 · Received October 2, 2025

    Report

    Report Number
    2015691-2025-08066
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 24, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    UDI-DI
    00690103213331
    PMA / PMN Number
    P220003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, D4, G3, G6, H2, H3, H4, H6 AND H11. H6 IMPACT CODE: NON-SERIOUS INJURY/ILLNESS/IMPAIRMENT H6 TYPE OF INVESTIGATION: LABELING REVIEW THE COMPLAINT FOR LOSS OF INTENDED GUIDE SHEATH POSITIONING WAS CONFIRMED WITH EMPIRICAL EVIDENCE. THE COMPLAINT FOR DEVICE NOT COMPLETELY DE-AIRED DURING FLUSHING AND PREPARATION WAS CONFIRMED WITH EMPIRICAL EVIDENCE. NO DEVICE OR IMAGING WAS PROVIDED FOR EVALUATION. AVAILABLE INFORMATION PROVIDED BY THE CLINICAL SPECIALIST STATES THAT THE GUIDE SHEATH POSITIONING WAS LOST AFTER REMOVING THE INTRODUCER. ADDITIONALLY, IT WAS STATED THAT THE GUIDEWIRE WAS REMOVED AND REINTRODUCED WHICH INDICATES THAT THE MANEUVERING OF THE INTRODUCER ALONG WITH THE REMOVAL AND REINTRODUCTION OF THE GUIDEWIRE MAY HAVE CONTRIBUTED TO THE LOSS OF POSITIONING AS WELL AS THE INTRODUCTION OF AIR. HOWEVER, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO NONCONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. B2: OTHER SERIOUS- EVEN THOUGH THERE WAS NO REINTERVENTION, THERE IS A POTENTIAL FOR REINTERVENTION IN THIS CASE. H6: IMPACT CODE - NON-SERIOUS INJURY/ILLNESS/IMPAIRMENT.

    Description of Event or Problem · 0

    PER REPORT RECEIVED FROM JAPAN, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION. ALTHOUGH CHORDAE WERE PRESENT AND THE CHORDAE-FREE ZONE (CFZ) WAS NARROW IN THIS CASE, THE DEVICE WAS GRASPED WHILE AVOIDING THE CHORDAE. BY OPTIMIZING THE POSTERIOR MITRAL LEAFLET (PML), MITRAL REGURGITATION (MR) WAS SUCCESSFULLY REDUCED. DURING GUIDE SHEATH (GS) INSERTION, AFTER REMOVING THE INTRODUCER, THE GS SLIPPED OUT FROM THE SEPTUM, LEADING TO AIR ENTRY DURING SUBSEQUENT WIRE AND CATHETER MANIPULATION. HOWEVER, THERE WERE NO ST CHANGES, AND THE AIR WAS ABSORBED BY THE END OF THE PROCEDURE. THE PATIENT SHOWED NO ISSUES WITH CONSCIOUSNESS UPON AWAKENING FROM ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276618 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS 66551748 00690103213331

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Other