BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVION FLX

    MDR report key: 16421799 · Received February 22, 2023

    Report

    Report Number
    2124215-2023-05574
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    February 3, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729978824
    PMA / PMN Number
    K180726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DEVICE CODE CORRECTED FROM FRACTURE A040101 TO DETACHMENT OF DEVICE OR DEVICE COMPONENT. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. UNIT RETURNED WITH ITS ORIGINAL BOX BATCH OVERALL VISUAL REVISION DID NOT IDENTIFY FAILURES OR EVIDENCE THAT COULD BE LOST DUE TO DECONTAMINATION PROCESS. THE DEVICE RETURNED TO THIS COMPLAINT, AND IT WAS OBSERVED THAT THE GUIDEWIRE WAS A FRACTURE IN THE DISTAL SECTION AND THE FRAGMENT WAS NOT RETURNED TO THIS COMPLAINT. A PART OF ORIGINAL BOX RETURNED, AND IT WAS OBSERVED THAT THE POUCH INFORMATION MATCHES WITH THE COMPLAINT INFORMATION. NO MORE DAMAGES WERE OBSERVED IN THE DEVICE. UNDER THE MICROSCOPE WAS OBSERVED THAT THE GUIDEWIRE WAS A FRACTURE IN THE DISTAL SECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING ARTERIAL PERIPHERAL VASCULAR PROCEDURE, THE DEVICE WAS FRACTURED. ATTEMPTS WERE MADE TO SNARE THE REMAINDER OF THE DEVICE AND AN ADDITIONAL FEMORAL ACCESS AND ADDITION SUPPLIES WERE NEEDED TO SNARE FROM A DIFFERENT APPROACH ALONG WITH APPROXIMATELY AN ADDITIONAL HOUR OF PROCEDURE TIME. EVENTUALLY, THE WIRE WAS STRAIGHTENED BY MULTIPLE MANIPULATIONS. THE FRACTURED PIECES WERE REMOVED BY A PEDAL ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE, AND THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING ARTERIAL PERIPHERAL VASCULAR PROCEDURE, THE DEVICE WAS FRACTURED. ATTEMPTS WERE MADE TO SNARE THE REMAINDER OF THE DEVICE AND AN ADDITIONAL FEMORAL ACCESS AND ADDITION SUPPLIES WERE NEEDED TO SNARE FROM A DIFFERENT APPROACH ALONG WITH APPROXIMATELY AN ADDITIONAL HOUR OF PROCEDURE TIME. EVENTUALLY, THE WIRE WAS STRAIGHTENED BY MULTIPLE MANIPULATIONS. THE FRACTURED PIECES WERE REMOVED BY A PEDAL ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE, AND THE PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134701 SAVION FLX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 1006 0029667601 08714729978824

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention