BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1242907 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04384
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EXAMINATION REVEALED SEVERAL KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT INSIDE THE INFLATION LUMEN OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION DEVICE AND DUE TO THE PRESENCE OF CONTRAST MEDIA, IT WAS NOT POSSIBLE TO INFLATE THE DEVICE. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. A RECOMMENDED SIZE PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC DE NOVO LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH AN APEX OTW BALLOON CATHETER AND A 2.0 X 20 MM MAVERICK BALLOON CATHETER WITH SIX INFLATIONS AT 18 TO 25 ATMS. THE PHYSICIAN ADVANCED THE 2.5 X 12 MM MAVERICK2 BALLOON CATHETER TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 12 ATMS FOR FIFTEEN SECONDS AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THERE WERE NO PATIENT COMPLICATIONS. THE STENOSIS AFTER DILATION WAS 80%, THEREFORE, THE PHYSICIAN SENT THE PT TO SURGERY. PT CONDITION POST SURGERY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 12 / 2.5 0012007242

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR RUNWAY 6F JL4