BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1080646 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02000
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS FOUND THAT THE BALLOON WAS TORN 2.8CM FROM THE TIP AND THAT THERE WAS NO DAMAGE SEEN IN THE REGION OF THE PROXIMAL BALLOON BOND. THE BALLOON CATHETER WAS ABLE TO TRACK THROUGH THE 8FR. GUIDE CATHETER THAT WAS RETURNED WITH THE DEVICE WITHOUT ISSUE. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE BALLOON TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE TEAR. NO OTHER DAMAGE WAS SEEN ALONG THE LENGTH OF THE CATHETER. THE MANUFACTURING RECORDS FOR THIS BATCH NUMBER HAVE BEEN REVIEWED AND CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE BALLOON TEAR CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT ANATOMICAL AND/OR PROCEDURAL FACTORS WERE ENCOUNTERED DURING THE PROCEDURE THAT LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED 2008: IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED, CALCIFIED, AND DE NOVO LESION WAS LOCATED IN AN UNSPECIFIED TORTUOUS RENAL ARTERY. AN UNSPECIFIED MACH1 GUIDE CATHETER WAS PLACED AND THE STERLING 7.0MM X 20MM BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION OF THE LESION. IT WAS NOT KNOWN HOW MANY INFLATIONS WERE MADE NOR TO WHAT ATMS THE BALLOON REACHED ON EACH INFLATION. UPON ATTEMPTING TO REMOVE THE BALLOON CATHETER, THE BALLOON WAS UNABLE TO BE WITHDRAWN THROUGH THE GUIDE CATHETER. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND GUIDE CATHETER AS A UNIT. UPON INSPECTION, THE PHYSICIAN NOTED THAT THE "TIP OF THE CATHETER LIFTED UP". AN 8FR MACH1 RCD1 GUIDE CATHETER AND AN UNSPECIFIED SYMMETRY BALLOON WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE". DEVICE ANALYSIS REVEALED A BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY BOSTON SCIENTIFIC NA 11067332

    Patients

    Seq Age Sex Outcome Treatment
    1 THRUWAY 0.018 GUIDE WIRE| PALMATZ 5MM X 1CM STENT