BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM XC

    MDR report key: 16268755 · Received January 30, 2023

    Report

    Report Number
    2124215-2023-02932
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    December 21, 2022
    Report Date
    May 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    UDI-DI
    08714729889892
    PMA / PMN Number
    K133023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS UPDATED IN FIRST SUPPLEMENTAL REPORT: B3- DATE OF EVENT CORRECTED B5- ADDITIONAL INFORMATION ADDED D4- MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, AND UNIQUE IDENTIFIER ADDED G4- PREMARKET / 510(K) # ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISTAL EMBOLIZATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A JETSTREAM ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, HOWEVER, A DISTAL EMBOLIZATION OCCURRED. AN ADDITIONAL ASPIRATION PROCEDURE WAS PERFORMED TO RELEASE THE EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISTAL EMBOLIZATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A JETSTREAM ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, HOWEVER, A DISTAL EMBOLIZATION OCCURRED. AN ADDITIONAL ASPIRATION PROCEDURE WAS PERFORMED TO RELEASE THE EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND THE EMBOLIZATION SITE WAS THE LEFT POPLITEAL ARTERY. CATHETERIZATION WAS ATTEMPTED, BUT IT WAS LEFT AS IT WAS BECAUSE IT WAS DIFFICULT TO TREAT. THEREFORE, THE PATIENT OUTCOME WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732705 JETSTREAM XC CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45007 0030089955 08714729889892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention