BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1905632 · Received November 23, 2010

    Report

    Report Number
    2134265-2010-05104
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE DEVICE FOUND A BREAK IN THE HYPOTUBE AT 72CM DISTAL TO THE STRAIN RELIEF. THE BREAK WAS NOT A COMPLETE CIRCUMFERENTIAL BREAK IN THE SHAFT AND AS A RESULT THE HYPOTUBE WAS INTACT, AS ONE UNIT. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON COULD NOT IDENTIFY ANY TEARS OR HOLES IN THE BALLOON MATERIAL. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND DURING AN ATTEMPT TO INFLATE LIQUID INTO THE BALLOON, THE LIQUID LEAKED OUT THROUGH THE BREAK SITE IN THE HYPOTUBE. AS A RESULT IT WAS NOT POSSIBLE TO TEST THE BALLOON FOR LEAKS. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE NON-CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.0X15MM MAVERICK2 BALLOON WAS ADVANCED TO BE USED FOR ANCHORING IN THE ACUTE CONUS BRANCH. THE BALLOON WAS INFLATED TO 8ATMS AND RUPTURED ON THE INITIAL INFLATION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE NON-CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.0X15MM MAVERICK2 BALLOON WAS ADVANCED TO BE USED FOR ANCHORING IN THE ACUTE CONUS BRANCH. THE BALLOON WAS INFLATED TO 8ATMS AND RUPTURED ON THE INITIAL INFLATION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE NON-CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.0X15MM MAVERICK2 BALLOON WAS ADVANCED TO BE USED FOR ANCHORING IN THE ACUTE CONUS BRANCH. THE BALLOON WAS INFLATED TO 8ATMS AND RUPTURED ON THE INITIAL INFLATION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND 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 - GALWAY H7493892815200 13663240

    Patients

    Seq Age Sex Outcome Treatment
    1