BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE II PRO BALLOON 1.00MM X 5MM

    MDR report key: 17059032 · Received June 2, 2023

    Report

    Report Number
    MW5118128
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 30, 2023
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAPPHIRE II PRO BALLOON 1.00MM X 5MM REF #(B)(4), LOT 4209872212, EXP 01/04/2025 MANUFACTURER ORBUSNEICH MEDICAL BALLOON WAS USED THAT HAD RESISTANCE WHEN ATTEMPTING TO REMOVE. ONCE REMOVED SAVED TO SHOW VENDOR PRODUCT. LESION WAS SEVERE COMPLICATED, BIFURCATION AND HAD BEEN TREATED PREVIOUSLY WITH STENT. PATIENT STABLE THROUGHOUT PROCEDURE, NO INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676172 SAPPHIRE II PRO BALLOON 1.00MM X 5MM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4209872212

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Other