BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSI, 4G 300-014

    MDR report key: 7582930 · Received June 8, 2018

    Report

    Report Number
    3006010712-2018-00010
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 24, 2018
    Report Date
    May 25, 2018
    Manufacturer
    BRIVANT LTD. T/A LAKE REGION MEDICAL RESEARCH CE
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT ATTACHMENT: [(B)(4) COMPLAINTINVESTIGATIONFORM.PDF].

    Description of Event or Problem · 0

    FROM: (B)(6). SENT: 25 MAY 2018 13:14. TO: (B)(6). SUBJECT: CSI COMPLAINT NOTIFICATION (B)(4). HELLO, PLEASE SEE BELOW FOR INFORMATION RELATING TO A COMPLAINT EVENT INVOLVING A GUIDE WIRE DISTRIBUTED BY CSI. PLEASE PROVIDE THE INTEGER COMPLAINT NUMBER WHEN AVAILABLE AND LET US KNOW IF ADDITIONAL INFORMATION IS NEEDED. DATE OF EVENT: (B)(6) 2018 CSI COMPLAINT NUMBER: (B)(4). CSI RMA NUMBER: (B)(4). EVENT DESCRIPTION: THE GUIDE WIRE WAS UNABLE TO CROSS THE SHORT SEGMENT CTO IN THE PT VESSEL. THE GUIDE WIRE PROLAPSED AND WAS REMOVED. IMAGING WAS PERFORMED AND A PERFORATION WAS NOTED. THE PERFORATION WAS RESOLVED FOLLOWING BALLOON ANGIOPLASTY AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. PRODUCT MODEL: 7-10049-02/901023-02. PRODUCT LOT: 10952275. DEVICE RETURNING: NO - DISCARDED. FACILITY: (B)(6). PHYSICIAN: DR. (B)(6). PATIENT GENDER: UNKNOWN. PATIENT AGE/DOB: UNKNOWN. PATIENT WEIGHT: UNKNOWN. ADDITIONAL EVENT INFORMATION: PLEASE SEE ATTACHED FOR ADDITIONAL EVENT INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE, ALONG WITH PROCEDURE IMAGES. THANK YOU, (B)(6).

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 1

    (B)(6). SUBJECT: CSI COMPLAINT NOTIFICATION (B)(4). HELLO, PLEASE SEE BELOW FOR INFORMATION RELATING TO A COMPLAINT EVENT INVOLVING A GUIDE WIRE DISTRIBUTED BY CSI. PLEASE PROVIDE THE INTEGER COMPLAINT NUMBER WHEN AVAILABLE AND LET US KNOW IF ADDITIONAL INFORMATION IS NEEDED. DATE OF EVENT: (B)(6) 2018, (B)(4). EVENT DESCRIPTION: THE GUIDE WIRE WAS UNABLE TO CROSS THE SHORT SEGMENT CTO IN THE PT VESSEL. THE GUIDE WIRE PROLAPSED AND WAS REMOVED. IMAGING WAS PERFORMED AND A PERFORATION WAS NOTED. THE PERFORATION WAS RESOLVED FOLLOWING BALLOON ANGIOPLASTY AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. PRODUCT MODEL: 7-10049-02/901023-02, PRODUCT LOT: 10952275, DEVICE RETURNING: NO - DISCARDED. FACILITY: (B)(6) MEDICAL CENTER, PHYSICIAN: DR. (B)(6). PATIENT GENDER: UNKNOWN, PATIENT AGE/DOB: UNKNOWN, PATIENT WEIGHT: UNKNOWN. ADDITIONAL EVENT INFORMATION: PLEASE SEE ATTACHED FOR ADDITIONAL EVENT INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE, ALONG WITH PROCEDURE IMAGES. THANK YOU, (B)(6). SR. QUALITY ASSURANCE SPECIALIST. CARDIOVASCULAR SYSTEMS, INC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425565 CSI, 4G 300-014 CSI, 4G 300-014 DQX BRIVANT LTD. T/A LAKE REGION MEDICAL RESEARCH CE 901060-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other