BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM SC

    MDR report key: 16274584 · Received January 31, 2023

    Report

    Report Number
    2124215-2023-02916
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    November 28, 2022
    Report Date
    March 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    UDI-DI
    08714729889830
    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 TO (B)(6) 2022; B5- ADDITIONAL INFORMATION ADDED; D1- BRAND NAME CORRECTED TO JETSTREAM SC; D4- MODEL NUMBER CORRECTED TO 45006, LOT NUMBER CORRECTED TO 0029298089, CATALOG NUMBER CORRECTED TO 45006; D4- ADDED UNIQUE IDENTIFIER ((B)(4)) ; G4- ADDED PREMARKET / 510(K)# (K133023); H4- ADDED DEVICE MANUFACTURE DATE (04/29/2022).

    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 FROM DUPLICATE EVENT (REPORT NUMBER 2124215-2022-56629) THAT A JETSTREAM SC CATHETER, 1.6MM AND A JETSTREAM XC CATHETER, 2.1MM WERE SELECTED FOR AN ENDOVASCULAR TREATMENT. HOWEVER, A DISTAL EMBOLIZATION OCCURRED IN THE LEFT ANTERIOR TIBIAL ARTERY DURING THE PROCEDURE. PERCUTANEOUS INTERVENTION WAS PERFORMED AND THE PATIENT WAS IN RECOVERY. THERE WERE NO DEVICE-RELATED PERFORMANCE ISSUES OBSERVED; HOWEVER, THE PHYSICIAN BELIEVED BOTH JETSTREAM CATHETERS WERE RELATED TO THE EMBOLIZATION. THE PATIENT HAS RECOVERED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897102 JETSTREAM SC CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45006 0029298089 08714729889830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention