BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1250353 · Received December 3, 2008

    Report

    Report Number
    2134265-2008-04568
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LIT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AV ANGIOPLASTY PROCEDURE, BALLOON DEFLATION ISSUES OCCURRED. THE LESION WAS LOCATED IN THE ARM IN AN ARTERIOVENOUS FISTULA. THE 2CM PERIPHERAL CUTTING BALLOON WAS ADVANCED ONCE WITHOUT DIFFICULTY TO THE LESION SITE AND INFLATED AS PER DIRECTIONS FOR USE (DFU). UPON THE ATTEMPT TO DEFLATE THE BALLOON, IT WOULD NOT DEFLATE. THE PHYSICIAN PUNCTURED THE BALLOON PERCUTANEOUSLY TO DEFLATE IT AND REMOVE IT WITH RESISTANCE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. PT STATUS WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON NA LIT BSC LETTERKENNY 8.00MM/2.0CM/90CM

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention THRUWAY GUIDE WIRE| TERUMO 7FR SHEATH| COOK INFLATION DEVICE