BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3934894 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-03986
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    March 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A MAVERICK 2 CATHETER WITH A MAVERICK 2 SHELF BOX. THE BATCH NUMBER ON THE PACKAGING AND DEVICE MATCHED THE REPORTED BATCH NUMBER. THERE WAS BLOOD IN THE BALLOON AND CONTRAST IN THE INFLATION LUMEN. THERE WERE MULTIPLE HYPOTUBE KINKS. MAGNIFIED INSPECTION REVEALED PINHOLE IN THE BALLOON MATERIAL ADJACENT TO THE DISTAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 2.00MM X 12MM MAVERICK² BALLOON CATHETER WAS SELECTED FOR USE TO INFLATE THE UNSPECIFIED TARGET LESION. WHEN THE PHYSICIAN INFLATED THE BALLOON, A LEAKAGE WAS FOUND AND NOTICED THAT THE BALLOON DIAMETER WAS NOT "GROWING." THE PHYSICIAN TOOK THE DEVICE OUT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414239 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892812200 16570966

    Patients

    Seq Age Sex Outcome Treatment
    1