BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK BALLOON DILATION CATHETER

    MDR report key: 1983876 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00207
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH A STOPCOCK ATTACHED TO THE MANIFOLD. BLOOD AND CONTRAST WERE VISIBLE THROUGHOUT THE DISTAL LUMEN. EXAMINATION OF THE DEVICE REVEALED TIP DAMAGE AND A LONGITUDINAL TEAR IN THE BALLOON WALL MATERIAL MEASURING PROXIMALLY 9MM IN LENGTH 0.25MM FROM BALLOON WAIST. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE BALLOON TEAR AND TIP 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 THROUGH ANOTHER MANUFACTURERS' INTRODUCER SHEATH VIA THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH THIS 5.0 / 20/153 MAVERICK XL BALLOON CATHETER. THE DEVICE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE TO THE LESION, THE BALLOON RUPTURED ON THE FIRST INFLATION AT RATED BURST PRESSURE AFTER BEING INFLATED FOR APPROXIMATELY TWO TO THREE SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A 6.0X15MM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANOTHER MANUFACTURERS' INTRODUCER SHEATH VIA THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH THIS 5.0 / 20/153 MAVERICK XL BALLOON CATHETER. THE DEVICE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE TO THE LESION, THE BALLOON RUPTURED ON THE FIRST INFLATION AT RATED BURST PRESSURE AFTER BEING INFLATED FOR APPROXIMATELY TWO TO THREE SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A 6.0X15MM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK BALLOON DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493790950200 12236904

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDIKIT INTRODUCER SHEATH