BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 21509858 · Received March 3, 2025

    Report

    Report Number
    2124215-2025-10247
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 1, 2025
    Report Date
    April 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729946106
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE DATE WAS NOT REPORTED. G4 PMA 510 K170204, K191008, K201178 INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE EVIDENCE FOUND WITHIN THE COMPLAINT WAS REVIEWED DURING THE COURSE OF THIS INVESTIGATION, AND BASED ON THAT EVIDENCE, THE COMPLAINT WAS CONFIRMED CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, AND THE CASE COULD NOT BE COMPLETED. THE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS SELECTED.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE DATE WAS NOT REPORTED. G4 PMA 510 K170204, K191008, K201178.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE IVUS PROCEDURE, ON THE FIRST CONNECTION WHEN THE OPTICROSS WAS INSERTED, THE IVUS SYSTEM POLARIS WAS INDICATED AS A SIMULATOR, AND IT WAS UNABLE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE IVUS PROCEDURE, ON THE FIRST CONNECTION WHEN THE OPTICROSS WAS INSERTED, THE IVUS SYSTEM POLARIS WAS INDICATED AS A SIMULATOR, AND IT WAS UNABLE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560604 ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H74939322120C0 0000202511 08714729946106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown