BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLO PATH

    MDR report key: 7855531 · Received September 7, 2018

    Report

    Report Number
    1118880-2018-00117
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    September 7, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION PRODUCT CODE/LOT NUMBER COMBINATION WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE AS CASE SPECIFICS COULD NOT BE VERIFIED PER THE DOCTOR.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    DURING A CONVERSATION WITH AN EXTERNAL CLINICIAN DOCTOR FOR A SOLOPATH PERFORMANCE FEEDBACK, IT WAS REPORTED THAT VALVE LEAKAGE WAS EXPERIENCED WITH THE DEVICE. THE DOCTOR STATED HE MOST FREQUENTLY USES THE SR-19XX AND HAS USED THE SR-22XX DEVICE ONCE. HE EXPECTS/EXPERIENCES VALVE LEAKAGE ALMOST EVERY PROCEDURE ON BOTH THE SR-19XX AND THE SR-22XX. THERE WAS AN UNACCEPTABLE LEVEL OF LEAKAGE EXPERIENCED WITH THE 0.035" GUIDEWIRE INSTALLED DURING THE PROCEDURE. THE DOCTOR WAS UNABLE TO PROVIDE A VOLUME OF BLOOD LOSS EXPERIENCED DURING A TYPICAL PROCEDURE DUE TO THE VALVE LEAKAGE, BUT HE DEFINED IT AS SIGNIFICANT. PATIENT CONDITION IS UNKNOWN. NO INTERVENTION SUCH AS BLOOD TRANSFUSION WAS REQUIRED AS A RESULT OF THE EXPERIENCED VALVE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696779 UNKNOWN SOLO PATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other