BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 3241372 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05089
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE MAVERICK OTW CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN A MAVERICK OTW PRODUCT POUCH AND SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL ALIGNED WITH THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS OBTUSE MARGINAL BRANCH ARTERY. A 7FCLS MACH 1 GUIDE CATHETER FOLLOWED BY A NON- BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. A 20MM 2.00 MAVERICK BALLOON CATHETER WAS SELECTED AND ADVANCED FOR PREDILATION. THE DEVICE WAS INFLATED TWICE, 1ST INFLATION IS AT 12ATMOSPHERES THEN RUPTURED ON THE 2ND INFLATION AT 16ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUSED OBTUSE MARGINAL BRANCH ARTERY. A 7FCLS MACH 1 GUIDE CATHETER FOLLOWED BY A NON- BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. A 20MM 2.00 MAVERICK BALLOON CATHETER WAS SELECTED AND ADVANCED FOR PREDILATION. THE DEVICE WAS INFLATED TWICE, 1ST INFLATION IS AT 12 ATMOSPHERES THEN RUPTURED ON THE 2ND INFLATION AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340333 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7492062020200 15874355

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: BMW| GUIDING CATHETER: MACH1 7FCLS