BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY BALLOON DILATATION CATHETER

    MDR report key: 1041263 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01358
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    February 25, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K993305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL RUNNING FROM 4MM DISTAL TO THE PROXIMAL BOND SITE TO 7MM FROM THE DISTAL BOND SITE. EXAMINATION OF THE RADIO OPAQUE (RO) MARKERBANDS NOTED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE TEAR IN THE BALLOON MATERIAL. NO OTHER DAMAGE WAS NOTED. THE MFG RECORDS FOR THIS BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE ROOT CAUSE OF THE BALLOON TEAR IS ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THAT LIMITED DEVICE PERFORMANCE. A CAPA HAS BEEN INITIATED TO ADDRESS THE ISSUE OF BALLOON LEAKS.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED 04/15/2008: IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A BALLOON LEAKAGE OCCURRED. THE 90% STENOSED, NON-CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERIOR VENA CAVA (SVC). ACCESS WAS OBTAINED VIA THE ANTEBRACHIUM", HOWEVER, IN WHICH ARM IS UNK. THE SYNERGY 12MM X 4MM BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 6ATMS. FLUOROSCOPIC IMAGINING WAS PERFORMED WHICH REVEALED A LEAK. THE BALLOON WAS REMOVED FROM THE PT WITHOUT INCIDENT AND ANOTHER OF THE SAME DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD". ANALYSIS REVEALED A BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 11150806

    Patients

    Seq Age Sex Outcome Treatment
    1 DEJAVE GUIDE WIRE| EVEREST INFLATION DEVICE| 7FR TERUMO INTRODUCER SHEATH