BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3231392 · Received July 17, 2013

    Report

    Report Number
    2134265-2013-04780
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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 MANUFACTURER: THE MAVERICK 2 CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, WATER EMITTED FROM TWO (2) HOLES IN THE BALLOON. THERE WAS A BALLOON PINHOLE ALIGNED WITH THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND AND A SECOND PINHOLE ALIGNED WITH THE DISTAL MARKERBAND. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. A 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED TO PREDILATE THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED BEFORE IT REACHED NOMINAL PRESSURE. THE DEVICE WAS RETRIEVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. A 2.50MM X 12MM MAVERICK² BALLOON CATHETER WAS ADVANCED TO PREDILATE THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED BEFORE IT REACHED NOMINAL PRESSURE. THE DEVICE WAS RETRIEVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330944 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892812250 15411114

    Patients

    Seq Age Sex Outcome Treatment
    1