BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETSTREAM® SC ATHERECTOMY CATHETER

    MDR report key: 6169092 · Received December 13, 2016

    Report

    Report Number
    2134265-2016-11453
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A JETSTREAM SC-1.85 ATHERECTOMY CATHETER IN ONE PIECE WITH NO OTHER DEVICES. THE DEVICE WAS CHECKED FOR ANY DAMAGE OR LEAKING ISSUES. DURING FUNCTIONAL TESTING NO ISSUES WITH FUNCTIONALITY OR LEAKING WAS NOTICED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT BROKE AND LEAKED. A 1.85MM JETSTREAM® SC ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE STENOSED PROXIMAL POPLITEAL. DURING PREPARATION OF THE DEVICE, THE PRIME BUTTON WAS PRESSED TO INITIATE PRIMING. AFTER PRIMING HAD COMPLETED, THERE APPEARED TO BE A BREAK AND LEAKING SALINE FROM THE BLACK CATHETER SHAFT. A SECOND PRIMING SEQUENCE WAS COMPLETED FOR CLOSER EXAMINATION. IT WAS DECIDED TO NOT USE THE DEVICE. A SECOND JETSTREAM CATHETER WAS SELECTED AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT BROKE AND LEAKED. A 1.85MM JETSTREAM® SC ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE STENOSED PROXIMAL POPLITEAL. DURING PREPARATION OF THE DEVICE, THE PRIME BUTTON WAS PRESSED TO INITIATE PRIMING. AFTER PRIMING HAD COMPLETED, THERE APPEARED TO BE A BREAK AND LEAKING SALINE FROM THE BLACK CATHETER SHAFT. A SECOND PRIMING SEQUENCE WAS COMPLETED FOR CLOSER EXAMINATION. IT WAS DECIDED TO NOT USE THE DEVICE. A SECOND JETSTREAM CATHETER WAS SELECTED AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821891 JETSTREAM® SC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC - MAPLE GROVE 112262-003 18671632

    Patients

    Seq Age Sex Outcome Treatment
    1