BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETSTREAM XC-2.4 CATHETER

    MDR report key: 4511751 · Received February 10, 2015

    Report

    Report Number
    2183460-2015-00012
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - (B)(4). QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED JETSTREAM XC-2.4 CATHETER, LOT NUMBER 183343. VISUAL EXAMINATION DETERMINED THAT THE MAILMAN GUIDEWIRE WAS STUCK INSIDE THE CATHETER. THE REMAINDER OF THE DEVICE APPEARED TO BE IN GOOD OVERALL CONDITION. THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND PASSED ALL REQUIREMENTS. FURTHER EXAMINATION OF THE GUIDEWIRE LUMEN CONFIRMED THAT THE BUSHING WAS OCCLUDED WITH TEFLON AND WAS NOT ABLE TO BE REMOVED. PRODUCT ANALYSIS CONCLUDED THAT THE GUIDEWIRE LOST COATING AND OCCLUDED THE BUSING AT THE DISTAL END OF THE CATHETER THEREBY CONTRIBUTING TO THE LOSS OF TRACTABILITY OF THE GUIDEWIRE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE JETSTREAM ATHERECTOMY CATHETER WAS BEING USED TO DEBULK AN OCCLUDED VESSEL. AFTER SEVERAL PASSES, THE CATHETER WAS REMOVED AND IMAGES WERE OBTAINED. THE PHYSICIAN DECIDED THAT HE WANTED TO PERFORM ATHERECTOMY ONCE AGAIN. HOWEVER, THE DEVICE BECAME STUCK ON THE MAILMAN GUIDEWIRE AND WAS NOT ABLE TO BE ADVANCED. THE CATHETER WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO USE A SECOND JETSTREAM CATHETER BUT IT BECAME STUCK ON THE GUIDEWIRE AS WELL. THE PHYSICIAN REMOVED THE JETSTREAM CATHETER WITH THE GUIDEWIRE, DECIDED THAT THE TREATMENT WAS SUCCESSFUL AND COMPLETED THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97276 JETSTREAM XC-2.4 CATHETER ATHERECTOMY CATHETER MCW BOSTON SCIENTIFIC 112266-001 183343

    Patients

    Seq Age Sex Outcome Treatment
    1