BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1950234 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05789
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. A DETAILED EXAMINATION OF THE BALLOON FOUND THAT A LONGITUDINAL TEAR WAS PRESENT IN THE BALLOON MATERIAL. THE TEAR STRETCHED FROM THE PROXIMAL END OF THE PROXIMAL MARKERBAND AND EXTENDED DISTALLY FOR A TOTAL LENGTH OF 6MM. A DETAILED EXAMINATION OF THE PROXIMAL MARKERBAND COULD NOT IDENTIFY ANY DAMAGE. AN APPROPRIATE SIZED MANDREL WAS INSERTED THROUGH THE TIP AND WIRE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE INDICATED IN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE 20MM X 2.0MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED TO THE LESION. DURING AN UNKNOWN INFLATION ATTEMPT, THE BALLOON BURST AT 14 ATMS. THE "PRESENCE OF BUBBLES" WAS NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD "SEVERE HYPOTENSION, ON A VERGE OF A HEART FAILURE". ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT FOR THE TARGET LESION LOCATED IN THE "STRONGLY CALCIFIED" MAIN RIGHT CORONARY ARTERY (RCA). A NON BSC GUIDE WIRE WAS PLACED DISTALLY IN THE RCA AND THE 20MM X 2.0MM MAVERICK 2 BALLOON CATHETER WAS "INFLATED SEVERAL TIMES" DURING PRE-DILATION. THE PREVIOUSLY NOTED SEVERE HYPOTENSION OCCURRED DURING AN UNKNOWN INFLATION AND THE SUBSEQUENT RUPTURE. THE PATIENT WAS TREATED WITH OXYGEN AND 0.3MG OF ADRENALINE AND THE ISSUE RESOLVED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH NOTED DIFFICULTY AFTER PLACING 2 NON BSC STENTS, A 3X24MM AND A 3X17MM, AND PERFORMING SEVERAL POST-DILATIONS. THE END RESULT WAS "SATISFYING" AND THE PATIENT'S STATUS WAS 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 H7493892820200 13906513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other