BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1832872 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03953
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER- EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED DISTAL TIP DAMAGE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TIP DAMAGE. NO ADDITIONAL DAMAGE WAS OBSERVED. THERE WAS BLOOD PRESENT IN THE SHAFT AND BALLOON. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE TO 12 ATM'S, FOR 5 MINUTES. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED BALLOON BURST, AS THERE WERE NO LEAKS/TEARS REVEALED WITH THE DEVICE. 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

    SAME CASE AS MFR# 2134265-2010-03955 AND 2134265-2010-03956. IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, THREE BALLOON RUPTURES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. FIRST, A 1.5X15MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 12ATMS AND RUPTURED AFTER 15 SECONDS. NEXT, THE PHYSICIAN USED A 15X2.0MM MAVERICK2 BALLOON AND A 20X1.5 MAVERICK2 BALLOON HOWEVER THESE ALSO RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT'S CONDITION IS LISTED AS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-03955 AND 2134265-2010-03956. IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, THREE BALLOON RUPTURES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. FIRST, A 1.5X15MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 12ATMS AND RUPTURED AFTER 15 SECONDS. NEXT, THE PHYSICIAN USED A 15X2.0MM MAVERICK2 BALLOON AND A 20X1.5 MAVERICK2 BALLOON HOWEVER THESE ALSO RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT'S CONDITION IS LISTED AS STABLE.

    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 H7493892815150 13488694

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ENCORE INFLATION DEVICE| 15X2.0 MAVERICK2 BALLOON CATHETER| 20X1.5 MAVERICK2 BALLOON CATHETER