BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 4191949 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06622
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 30, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A MAVERICK 2 BALLOON CATHETER. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED NO DAMAGE. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING AN INFLATION DEVICE FILLED WITH WATER TO THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED, A STREAM OF WATER EMITTED FROM THE BALLOON WALL. THE BALLOON WAS MICROSCOPICALLY EXAMINED AND A PINHOLE IN THE BALLOON WALL 0.5MM DISTAL OF THE DISTAL MARKERBAND (IN THE BALLOON CONE) WAS REVEALED. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 15MM MAVERICK²¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 15MM MAVERICK²¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671711 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815250 16462305

    Patients

    Seq Age Sex Outcome Treatment
    1