BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3914107 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03903
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. VISUAL AND TACTILE INSPECTION WAS PERFORMED. THE DEVICE WAS RETURNED IN ONE PIECE AND THERE WAS CONTRAST IN THE INFLATION LUMEN. THE HYPOTUBE WAS KINKED 20CM FROM THE STRAIN RELIEF AND THERE WERE NUMEROUS BENDS; HOWEVER THE SHAFT WAS NOT BROKEN. INSPECTION OF THE DEVICE UNDER MAGNIFICATION PRESENTED NO DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 30X3.5 MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A NON-CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION WITH AN UNSPECIFIED BALLOON CATHETER, UNSPECIFIED STENTS WERE IMPLANTED IN THE TARGET LESION. A 3.5MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS THEN USED FOR POSTDILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT (ABOUT 20CM AWAY FROM THE HUB) WAS BROKEN OFF. THE PHYSICIAN THEN USED THE GUIDING TO WITHDREW THE DEVICE COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5*15MM QM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED.   THE 90% STENOSED, 30X3.5 MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A NON-CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION WITH AN UNSPECIFIED BALLOON CATHETER, UNSPECIFIED STENTS WERE IMPLANTED IN THE TARGET LESION. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN USED FOR POSTDILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT (ABOUT 20CM AWAY FROM THE HUB) WAS BROKEN OFF. THE PHYSICIAN THEN USED THE GUIDING TO WITHDREW THE DEVICE COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5*15MM QM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390705 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015350 16514315

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR