BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM ATHERECTOMY CATHETER

    MDR report key: 14880642 · Received June 30, 2022

    Report

    Report Number
    2134265-2022-07288
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 12, 2021
    Report Date
    June 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE OF PUBLICATION USED AS EVENT DATE. INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL REPORTER CITY: (B)(6). CHOI, JONG HYUN, ET AL. "SUCCESSFUL MANAGEMENT OF IATROGENIC ARTERIAL PSEUDOANEURYSM CAUSED BY ROTATIONAL ATHERECTOMY." CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 37.2 (2022): 391-392.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT A PSEUDOANEURYSM OCCURRED. A 71-YEAR-OLD MAN VISITED OUR HOSPITAL DUE TO DETERIORATION OF THE DM FOOT. ON THE COMPUTED TOMOGRAPHY(CT) IMAGE, A 31 MM-SIZED PSEUDOANEURYSM WAS OBSERVED AT THE PREVIOUS PLACED NON-BSC 7X39 MM STENT 7X39 MM INSERTION SITE. ENDOVASCULAR THERAPY (EVT) WAS PERFORMED 18 MONTHS AGO, AT ANOTHER HOSPITAL, FOR IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED STENT. ATHERECTOMY WAS PERFORMED USING A JETSTREAM XC ATHERECTOMY CATHETER 2.4/3.4 MM, AND A DRUG-COATED BALLOON. HOWEVER, SEVERAL MONTHS AFTER THE PROCEDURE, A PSEUDOANEURYSM OCCURRED, AND DID NOT IMPROVE AFTERWARDS, SO THE PATIENT VISITED OUR HOSPITAL FOR TREATMENT. THE X-RAY AND FLUOROSCOPY REVEALED THE PREVIOUS PLACED NON-BSC STENT HAD STRUT DAMAGE. EVT WAS PERFORMED USING A NON-BSC COVERED STENT. ON THE ANGIOGRAM, A HUGE ANEURYSM COMMUNICATING FROM SUPERFICIAL FEMORAL ARTERY WAS FOUND. THE STENT WAS PLACED ACCURATELY AT BIFURCATION SITE. ON THE FINAL ANGIOGRAPHY, PSEUDOANEURYSM WAS COMPLETELY CEILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549313 JETSTREAM ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention