BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1250484 · Received November 26, 2008

    Report

    Report Number
    MW5009099
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO RIGHT RENAL ARTERY. DURING PROCEDURE, CUTTING BALLOON WOULD NOT DEFLATE. EVENTUALLY ABLE TO DEFLATE BALLOON AND REMOVES DEVICE AFTER SEVERAL ATTEMPTS. PT EXPERIENCED SOME POST-OPERATIVE BLEEDING WITH A DROP IN HEMOGLOBIN. PT WAS STABILIZED AND DISCHARGED TO HOME IN 2008. PT WAS TO HAVE A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF THE RIGHT RENAL ARTERY. A PERIPHERAL CUTTING BALLOON WAS USED IN THE COURSE OF THIS PROCEDURE. THIS CUTTING BALLOON DID NOT DEFLATE AS EXPECTED. SEVERAL ATTEMPTS TO DEFLATE THE BALLOON WERE ATTEMPTED. WHEN THE BALLOON WAS REMOVED, THE SHEATH WAS NOTED TO BE SPLIT. THE PT DID EXPERIENCE POST PROCEDURE BLEEDING THAT WAS EVENTUALLY CONTROLLED. THE PT EXPERIENCED NO LONG TERM HARM, AND WAS DISCHARGED TO HOME. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RIGHT RENAL ARTERY STENOSIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT APPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PERIPHERAL CUTTING BALLOON LIT BOSTON SCIENTIFIC PCB5020135 EJ5288
    2 PERIPHERAL CUTTING BALLOON LIT BOSTON SCIENTIFIC PCBS020135 062708

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention