BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETSTREAM XC

    MDR report key: 9272972 · Received November 4, 2019

    Report

    Report Number
    2134265-2019-13330
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    UDI-DI
    08714729889922
    PMA / PMN Number
    K133023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS CONSISTED OF A JETSTREAM XC 2.4MM ATHERECTOMY CATHETER. THE DEVICE WAS VISUALLY EXAMINED AND IT WAS NOTICED THAT THERE WAS SHAFT DAMAGE IN THE FORM OF BUCKLING/KINKS LOCATED AT 126CM FROM THE TIP PROXIMAL. THE INFUSION LINE HAD BURST PROXIMAL THE BUCKLING/KINKS, LOCATED APPROXIMATELY 5CM TO 16CM FROM THE TIP. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE A SEVERELY DAMAGED OF THE SHEATH. THE DAMAGE THAT WAS NOTICED WAS CONSISTENT WITH SHEATH INTERFERENCE DURING THE PROCEDURE OR BY PUSHING, PULLING AND TORQUEING OF THE DEVICE IN A TORTUOUS ANATOMY OR A HEAVILY CALCIFIED LESION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER LINER OF THE DEVICE PEELED AND DIFFICULTY REMOVING OCCURRED. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE JETSTREAM CATHETER HAD DIFFICULTY TO CROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, HE DID NOT HIT THE REX BUTTON IMMEDIATELY AND EXPERIENCED RESISTANCE WHEN REMOVING THE DEVICE FROM THE PATIENT. AT THAT POINT, THE PHYSICIAN HIT THE REX BUTTON AND THE DEVICE WOULD NOT COMPLETELY ACTIVATE IN REX AND HE HAD TO REMOVE THE SYSTEM FROM THE PATIENT WITHOUT REX. THE REX WOULD NOT ENGAGE OR ADVANCE THE SHEATH. THERE WAS DIFFICULT TO REMOVE THE CATHETER THROUGH THE NON-BSC SHEATH, IT WAS PULLED THE SHEATH AND CATHETER TOGETHER. UPON VISUAL INSPECTION OF THE DEVICE, IT WAS NOTICED THAT THE CLEAR PROTECTIVE COVERING AT THE DISTAL END OF THE JETSTREAM CATHETER HAD SHEARED AND WAS PROHIBITING THE CATHETER FROM BEING REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066348 JETSTREAM XC CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45007 0023422100 08714729889922

    Patients

    Seq Age Sex Outcome Treatment
    1