BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLO PATH

    MDR report key: 7855525 · Received September 7, 2018

    Report

    Report Number
    1118880-2018-00116
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. FOR THIS REASON, EVALUATION CODE HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION. 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 MENTIONED THAT VALVE LEAKAGE WAS EXPERIENCED WITH THE DEVICE. THE DOCTOR STATED HE MOST FREQUENTLY USES THE SR-22XX AND SR-24XX DEVICES, AND LESS FREQUENTLY USES THE SR-19XX DEVICES. HE EXPECTS/EXPERIENCES VALVE LEAKAGE ALMOST EVERY PROCEDURE ON ALL SR PRODUCT SIZES AND UNACCEPTABLE LEVEL OF LEAKAGE, 200ML OF BLOOD LOSS PER HOUR WITH STIFF GUIDEWIRE INSTALLED AFTER INITIAL DEVICE INSERTION DURING AN AVERAGE PROCEDURE. 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
    696773 UNKNOWN SOLO PATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other