BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSI, 4G 300-014

    MDR report key: 7569325 · Received June 5, 2018

    Report

    Report Number
    3006010712-2018-00009
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 7, 2018
    Manufacturer
    BIRIVANT LTD. T/A LAKE REGION MEDICAL RESEARCH CEN
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    (B)(6). HELLO, PLEASE SEE ADDITIONAL INFORMATION REGARDING THIS EVENT ATTACHED. PLEASE LET US KNOW IF ADDITIONAL INFORMATION IS REQUIRED. UPDATED EVENT DESCRIPTION: DURING TREATMENT OF A CTO, THE TIP OF THE GUIDE WIRE BECAME DETACHED WHILE ADVANCING IT THROUGH THE LESION IN A SEE-SAW MOTION. THE WIRE FRAGMENT WAS UNABLE TO BE REMOVED AND THE PROCEDURE WAS ABORTED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. LOT NUMBER: 10953507 THANK YOU, (B)(6). LEADING THE WAY BY DEVELOPING AND COMMERCIALIZING INNOVATIVE SOLUTIONS FOR TREATING PERIPHERAL ARTERY DISEASE (PAD) AND CORONARY ARTERY DISEASE (CAD). (B)(6). 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. DATE OF EVENT: (B)(6) 2018. CSI COMPLAINT NUMBER: 05724. CSI RMA NUMBER: (B)(4). EVENT DESCRIPTION: THE TIP BROKE OFF OF THE GUIDE WIRE DURING EVALUATION. PRODUCT MODEL: 7-10049-02/901023-02. PRODUCT LOT: UNKNOWN. DEVICE RETURNING: UNKNOWN. FACILITY: (B)(6). PHYSICIAN: DR. (B)(6). PATIENT GENDER: UNKNOWN . PATIENT AGE/DOB: UNKNOWN . PATIENT WEIGHT: UNKNOWN . ADDITIONAL EVENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE FORWARDED WHEN RECEIVED. 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: RE: CSI COMPLAINT NOTIFICATION. HELLO, PLEASE SEE ADDITIONAL INFORMATION REGARDING THIS EVENT ATTACHED. PLEASE LET US KNOW IF ADDITIONAL INFORMATION IS REQUIRED. UPDATED EVENT DESCRIPTION: DURING TREATMENT OF A CTO, THE TIP OF THE GUIDE WIRE BECAME DETACHED WHILE ADVANCING IT THROUGH THE LESION IN A SEE-SAW MOTION. THE WIRE FRAGMENT WAS UNABLE TO BE REMOVED AND THE PROCEDURE WAS ABORTED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. LOT NUMBER: 10953507. THANK YOU, (B)(6). SR. QUALITY ASSURANCE SPECIALIST. CARDIOVASCULAR SYSTEMS, INC (B)(6). LEADING THE WAY BY DEVELOPING AND COMMERCIALIZING INNOVATIVE SOLUTIONS FOR TREATING PERIPHERAL ARTERY DISEASE (PAD) AND CORONARY ARTERY DISEASE (CAD). (B)(6). SUBJECT: CSI COMPLAINT NOTIFICATION. 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. DATE OF EVENT: (B)(6) 2018. (B)(4). EVENT DESCRIPTION: THE TIP BROKE OFF OF THE GUIDE WIRE DURING EVALUATION. PRODUCT MODEL: 7-10049-02/901023-02. PRODUCT LOT: UNKNOWN. DEVICE RETURNING: UNKNOWN. FACILITY: (B)(6) CENTER. PHYSICIAN: DR. (B)(6). PATIENT GENDER: UNKNOWN. PATIENT AGE/DOB: UNKNOWN. PATIENT WEIGHT: UNKNOWN. ADDITIONAL EVENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE FORWARDED WHEN RECEIVED. THANK YOU, (B)(6). SR. QUALITY ASSURANCE SPECIALIST CARDIOVASCULAR SYSTEMS, INC (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411646 CSI, 4G 300-014 CSI, 4G 300-014 DQX BIRIVANT LTD. T/A LAKE REGION MEDICAL RESEARCH CEN CSI, 4G 300-014 10953507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other