BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1990397 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00359
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    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

    (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 ANALYSIS REVEALED A PINHOLE LEAK WAS IDENTIFIED IN THE BALLOON MATERIAL. THE LEAK WAS LOCATED APPROXIMATELY 5MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. A DETAILED MICROSCOPIC EXAMINATION OF THE MARKERBAND AND BALLOON MATERIAL COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE LEAK. 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 A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). A 15MM X 2.0MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE DILATION. ON THE FIRST INFLATION THE BALLOON WAS INFLATED TO 6ATMS FOR FIVE SECONDS, AND A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). A 15MM X 2.0MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE DILATION. ON THE FIRST INFLATION THE BALLOON WAS INFLATED TO 6ATMS FOR FIVE SECONDS, AND A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS FINE.

    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 H7493892815200 13624731

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INFLATION DEVICE, ENCORE| GUIDE CATHETER, BRITE TIP XBLAD 3.5 SH| GUIDE WIRE, 0.014 INCH NEOS ROUTE