BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 25171688 · Received May 14, 2026

    Report

    Report Number
    2124215-2026-26081
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729946106
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN OBTAINED.

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN OBTAINED. G4: PREMARKET / 510(K) # K151613, K170204, K191008, K201178.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. A POLARIS MMG IMAGING SYSTEM WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE EQUIPMENT FAILED TO POWER ON, AND NOISE WAS OBSERVED FROM THE ACQUISITION PC. ATTEMPTS TO RESTART THE SYSTEM WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT REQUIRED A PROLONGED HOSPITAL STAY, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. A POLARIS MMG IMAGING SYSTEM WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE EQUIPMENT FAILED TO POWER ON, AND NOISE WAS OBSERVED FROM THE ACQUISITION PC. ATTEMPTS TO RESTART THE SYSTEM WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT REQUIRED A PROLONGED HOSPITAL STAY WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS CANCELLED DUE TO THE CONSOLE NOT WORKING. AS A RESULT, THE PATIENT WAS EITHER RESCHEDULED OR TREATED WITHOUT IVUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432896 ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H74939322120C0 0000301847 08714729946106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown