BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSI,30G 300-014

    MDR report key: 8398314 · Received March 7, 2019

    Report

    Report Number
    3006010712-2018-00021
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 5, 2019
    Manufacturer
    BRIVANT LTD. T/A LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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

    CSI NOTIFIED LRM OF THE BELOW EVENT: PROCEDURE DESCRIPTION: A SEVERELY CALCIFIED, 10-15 CM LONG LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMATER WAS 5-6 MM WITH A TOTAL OCCLUSION OF THE DISTAL SFA. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH MULTIPLE WIRES AND THEN TRIED WITH A .014 ZILIENT WIRE. THE GUIDE WIRE ADVANCED THROUGH THE LESION FURTHER THAN THE OTHER ATTEMPTS, BUT DID NOT COMPLETELY CROSS THE LESION AND KINKED. THE GUIDE WIRE WAS REMOVED, AND A SECOND .014 ZILIENT GUIDE WIRE WAS ADVANCED INTO THE LESION. A TORQUE DEVICE WAS USED WITH THE SECOND ZILIENT GUIDE WIRE, HOWEVER IT WAS UNABLE TO CROSS THE LESION. AS THE GUIDE WIRE WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED FROM THE SHAFT. THE TIP OF THE GUIDE WIRE REMAINED IN THE DISTAL SFA AT THE END OF THE PROCEDURE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THE PHYSICIAN WAS PLANNING A SECOND PROCEDURE TO ATTEMPT TO RETRIEVE THE FRACTURED TIP. THIS COMPLAINT HAS BEEN OPENED TO INVESTIGATE THE SECOND EVENT DESCRIBED IN THE COMPLAINT TEXT: EVENT 2: (B)(4) EVENT DESCRIPTION: DURING A PROCEDURE, THE TIP OF THE ZILIENT GUIDE WIRE FRACTURED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. PRODUCT MODEL: 30G-300-014 . PRODUCT LOT: 10987615 . DEVICE RETURNING: ANTICIPATED . (B)(4) HAS BEEN OPENED TO INVESTIGATE EVENT 1, FAILURE TO ADVANCE/KINKED WIRE. (B)(4) IS FOR FRACTURED TIP.

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 1

    CSI NOTIFIED LRM OF THE BELOW EVENT: PROCEDURE DESCRIPTION: A SEVERELY CALCIFIED, 10-15 CM LONG LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMATER WAS 5-6 MM WITH A TOTAL OCCLUSION OF THE DISTAL SFA. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH MULTIPLE WIRES AND THEN TRIED WITH A .014 ZILIENT WIRE. THE GUIDE WIRE ADVANCED THROUGH THE LESION FURTHER THAN THE OTHER ATTEMPTS, BUT DID NOT COMPLETELY CROSS THE LESION AND KINKED. THE GUIDE WIRE WAS REMOVED, AND A SECOND .014 ZILIENT GUIDE WIRE WAS ADVANCED INTO THE LESION. A TORQUE DEVICE WAS USED WITH THE SECOND ZILIENT GUIDE WIRE, HOWEVER IT WAS UNABLE TO CROSS THE LESION. AS THE GUIDE WIRE WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED FROM THE SHAFT. THE TIP OF THE GUIDE WIRE REMAINED IN THE DISTAL SFA AT THE END OF THE PROCEDURE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THE PHYSICIAN WAS PLANNING A SECOND PROCEDURE TO ATTEMPT TO RETRIEVE THE FRACTURED TIP. THIS COMPLAINT HAS BEEN OPENED TO INVESTIGATE THE SECOND EVENT DESCRIBED IN THE COMPLAINT TEXT: EVENT 2: (B)(4). EVENT DESCRIPTION: DURING A PROCEDURE, THE TIP OF THE ZILIENT GUIDE WIRE FRACTURED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. PRODUCT MODEL: 30G-300-014, PRODUCT LOT: 10987615, DEVICE RETURNING: ANTICIPATED. (B)(4) HAS BEEN OPENED TO INVESTIGATE EVENT 1, FAILURE TO ADVANCE/KINKED WIRE. (B)(4) IS FOR FRACTURED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191008 CSI,30G 300-014 CSI,30G 300-014 DQX BRIVANT LTD. T/A LAKE REGION MEDICAL 901060-10 10987615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other