BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1833671 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04109
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED BLOOD AND CONTRAST THROUGHOUT THE DISTAL LUMEN AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED. MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED A BROKEN HYPOTUBE SEPARATED AT 54CM FROM PROXIMAL EDGE OF THE MANIFOLD. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. NO FURTHER DAMAGE WAS FOUND. 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 DURING AN UNSPECIFIED PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE DIAGONAL ARTERY. UPON ATTEMPTING TO PLACE THE 9MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER IN THE PATIENT'S BODY, THE SHAFT OF THE BALLOON CATHETER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE DIAGONAL ARTERY. UPON ATTEMPTING TO PLACE THE 9MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER IN THE PATIENT¿S BODY, THE SHAFT OF THE BALLOON CATHETER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892809250 13476956

    Patients

    Seq Age Sex Outcome Treatment
    1