BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 839013 · Received April 12, 2007

    Report

    Report Number
    6000089-2007-00544
    Event Type
    Injury
    Date Received
    April 12, 2007
    Date of Event
    March 14, 2007
    Report Date
    March 14, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQY
    PMA / PMN Number
    k011889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K) # K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT UPPER EXTREMITY FISTULA ANGIOPLASTY TREATMENT PROCEDURE, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT, "DURING THE PROCEDURE, [THE] BALLOON WOULD NOT DEFLATE. MD HAD TO USE NEEDLE TO DEFLATE THE BALLOON." THE LESION BEING TREATED WAS A 90% STENOTIC, NON-CALCIFIED, DE NOVO LESION WHICH WAS NOT PREDILATED. THE PHYSICIAN HAD NO DIFFICULTY PREPPING OR INFLATING THE BALLOON, BUT THE NUMBER OF ATMS REACHED IS UNKNOWN, AS THE BALLOON WAS MANUALLY INFLATED WITHOUT AN INFLATION DEVICE. THE BALLOON WAS INFLATED FOR 10 SECONDS BEFORE THE PHYSICIAN ATTEMPTED DEFLATION, AND FOR APPROXIMATELY 2 MINUTES TOTAL INFLATION TIME BEFORE IT WAS REMOVED. THE PATIENT WAS ASYMPTOMATIC DURING THIS EVENT. A TRANSCUTANEOUS PUNCTURE WITH A 25 GAUGE NEEDLE WAS PERFORMED TO DEFLATE THE BALLOON. THE BALLOON WAS FULLY DEFLATED WHEN REMOVED AND IN AN INTACT CONDITION. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THE BALLOON DEFLATION DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. PATIENT STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORP. NA 8638391

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ANGLED GLIDEWIRE 150CM