BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY BALLOON DILATATION CATHETER

    MDR report key: 962156 · Received May 4, 2007

    Report

    Report Number
    6000089-2007-00655
    Event Type
    Malfunction
    Date Received
    May 4, 2007
    Date of Event
    January 24, 2007
    Report Date
    April 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    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

    DEVICE ANALYSIS: DEVICE ANALYSIS CONFIRMED THAT A BALLOON PINHOLE WAS VISIBLE APPROXIMATELY 1MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AT THE LEAK SITE COULD NOT IDENTIFY ANY ISSUES WITH THE BALLOON OR THE DISTAL MARKERBAND THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE OCCURRENCE OF THE PINHOLE LEAK. A REVIEW OF THE MANUFACTURING RECORD FOR BATCH 9230412 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBL, AND PRODUCT SPECIFICATIONS. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR BATCH 9230412. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON 04/26/2007. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON INFLATION DIFFICULITES OCCURRED. THE LONG, DIFFUSE LESION LOCATED IN THE LEFT COMMON ILIAC ARTERY WAS 80% STENOTIC WITH CALCIFICATION. THE PHYSICIAN CROSSED THE LESION WITH A 0.035" GUIDEWIRE AND PREDILATED WITH A 6MM X 40MM BALLOON. FOLLOWING PREDILATION, THE PHYSICIAN DEPLOYED A STENT FROM THE COMMON ILIAC BIFURCATION TO THE INTERNAL ILIAC ARTERY. THE STENT REQUIRED POST- DILATION AND WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THIS BALLOON, IT WAS NOT ABLE TO DILATE THE STENT AT 4 ATMS AND BLOOD ENTERED THE INFLATION DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SIZE OF THE SAME BALLOON. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE CURRENT PATIENT CONDITION IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORP. NA 0009230412

    Patients

    Seq Age Sex Outcome Treatment
    1 * BSC WALLSTEN 8MM X 47MM| TERUMO RADIOFOCUS 0.035" GUIDEWIRE| BSC 8MM X 20MM SYNERGY BALLOON| BSC 6MM X 40MM SYNERGY BALLOON