BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 (TM)

    MDR report key: 2173428 · Received July 23, 2011

    Report

    Report Number
    2134265-2011-02734
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE COULD FIND NO TEARS IN THE BALLOON MATERIAL. HOWEVER, WHEN THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT, A PINHOLE LEAK WAS NOTED OVER THE CENTER OF THE PROXIMAL MARKERBAND. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND OF THE PROXIMAL MARKERBAND, COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE LEAK. NO ISSUES EXISTED WITH THE PROFILE OF THE TIP SECTION OF 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 # 2134265-2011-02753. SAME PATIENT AS MFR# 2134265-2011-02934, 2134265-2011-02935, 2134265-2011-0294. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE TAXUS EXPRESS2 STENTS, SIZE 3.0X12MM, 3.0X32MM, AND 2.5X24MM, WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO YEARS LATER, A 3.5X18MM NON-BSC STENT WAS PLACED IN THE PROXIMAL LAD. TWO YEARS LATER, IN-STENT RESTENOSIS WAS NOTED IN. IVUS WAS NOT PERFORMED. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT IN-STENT RESTENOSIS OF THE LAD. WHILE ADVANCING A 20X2.0MM MAVERICK2 MONORAIL BALLOON CATHETER RESISTANCE WAS ENCOUNTERED PROXIMAL TO THE 3.5X18MM NON-BSC STENT. THE BALLOON CATHETER CROSSED THE TARGET LESION, HOWEVER PRIOR TO INFLATION, WHEN APPLYING NEGATIVE PRESSURE "BLOOD FLEW BACK." THE PHYSICIAN SUSPECTED THAT THE BALLOON HAD ALREADY RUPTURED. THE DEVICE WAS REMOVED INTACT AND EXCHANGED FOR ANOTHER 20X2.0MM MAVERICK2 BALLOON CATHETER. THE 20X2.0MM MAVERICK2 CATHETER WAS ADVANCED TO THE LESION AND AGAIN PRIOR TO INFLATION, "BLOOD FLEW BACK". IT WAS NOTED THAT THIS BALLOON HAD ALSO RUPTURED. THE MAVERICK2 CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A FLEXTOME AND NON-BSC CUTTING BALLOON. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2011-02753. SAME PATIENT AS MFR# 2134265-2011-02935, 2134265-2011-0294 IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE TAXUS EXPRESS2 STENTS, SIZE 3.0X12MM, 3.0X32MM, AND 2.5X24MM, WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO YEARS LATER, A 3.5X18MM NON-BSC STENT WAS PLACED IN THE PROXIMAL LAD. TWO YEARS LATER, IN-STENT RESTENOSIS WAS NOTED IN. IVUS WAS NOT PERFORMED. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT IN-STENT RESTENOSIS OF THE LAD. WHILE ADVANCING A 20X2.0MM MAVERICK2 MONORAIL BALLOON CATHETER RESISTANCE WAS ENCOUNTERED PROXIMAL TO THE 3.5X18MM NON-BSC STENT. THE BALLOON CATHETER CROSSED THE TARGET LESION, HOWEVER PRIOR TO INFLATION, WHEN APPLYING NEGATIVE PRESSURE "BLOOD FLEW BACK." THE PHYSICIAN SUSPECTED THAT THE BALLOON HAD ALREADY RUPTURED. THE DEVICE WAS REMOVED INTACT AND EXCHANGED FOR ANOTHER 20X2.0MM MAVERICK2 BALLOON CATHETER. THE 20X2.0MM MAVERICK2 CATHETER WAS ADVANCED TO THE LESION AND AGAIN PRIOR TO INFLATION, "BLOOD FLEW BACK". IT WAS NOTED THAT THIS BALLOON HAD ALSO RUPTURED. THE MAVERICK2 CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A FLEXTOME AND NON-BSC CUTTING BALLOON. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK 2 (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820200 0013299752

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR