BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 8663970 · Received June 3, 2019

    Report

    Report Number
    2134265-2019-06299
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729369967
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A MAVERICK 2 BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ALONG THE HYPOTUBE. THE HYPOTUBE IS SEPARATED 90.8CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND ON THE BALLOON FOLDS. THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE BALLOON SHAFT AND THE DELIVERY SHAFT WERE FRACTURED AND THE GUIDE WIRE PORT WAS KINKED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE BALLOON SHAFT AND THE DELIVERY SHAFT WERE FRACTURED AND THE GUIDE WIRE PORT WAS KINKED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456632 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7580 0022756494 08714729369967

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR