BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 856723 · Received May 25, 2007

    Report

    Report Number
    6000089-2007-00749
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    April 24, 2007
    Report Date
    April 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER'S REPORT# 6000079-2007-00750. IT WAS REPORTED THAT DURING A PULMONARY ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PACKAGING OF THE BLUE MAX BALLOON STATED THAT IT SHOULD GO THROUGH A 7F SHEATH, AND IT WAS INITIALLY ADVANCED THROUGH THE SHEATH, BUT AFTER INFLATING THEN DEFLATING THE BALLOON IT COULD NOT BE REMOVED THROUGH THE 7F SHEATH. THE PHYSICIAN INCREASED THE FRENCH SIZE TO A 10F SHEATH AND THE BALLOON WAS RETRIEVED WITH GREAT DIFFICULTY. HE HAD TO PULL THE BALLOON OUT AT THE SAME TIME AS THE SHEATH. THE PHYSICIAN THE ATTEMPTED AN XXL BALLOON. THE BALLOON WAS ADVANCED THROUGH A 10 FRENCH SHEATH INSTEAD OF A 7F SHEATH AS INDICATED ON THE PACKAGING. AFTER INFLATION AND DEFLATION, IT WAS DIFFICULT TO PULL THIS BALLOON BACK THROUGH THE SHEATH ALSO. THE PROCEDURE WAS COMPLETED WITH GREAT DIFFICULTY. IT WAS REPORTED THAT THERE WERE NO INJURIES OR COMPLICATIONS FOR THE PT. PT STATUS IS REPORTED AS "FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR