BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 863601 · Received March 6, 2007

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    9610978-2007-00132
    Event Type
    Malfunction
    Date Received
    March 6, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 20, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER WITH LOT NUMBER. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. IN THIS CASE, LESION/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE LEFT POPLITEAL ARTERY BALLOON WAS REPORTED TO HAVE RUPTURED. THE VESSEL WAS MODERATELY CALCIFIED WITH A 90% STENOSIS. NO TORTUOSITY WAS PRESENT. THE LESION WAS INITIALLY DILATED WITH A SAVVY BALLOON. NEXT A SLALOM THRILL BALLOON WAS POSITIONED WITHIN THE TARGET LESION AND INFLATED WITH AN INDEFLATOR. HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES, BELOW THE RATED BURST PRESSURE OF 18 ATM. NO ADDITIONAL PATIENT, LESION OR PROCEDURAL DETAILS WERE PROVIDED. IT IS UNKNOWN IF DIFFICULTY WAS EXPERIENCED WHILE ADVANCING THE BALLOON CATHETER TO THE LESION OR WHILE CROSSING THE LESION. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN (DIABETES, PVD). GIVEN THAT THE VESSEL WAS MODERATELY CALCIFIED, AND THE LESION IS SOMEWHAT DISTAL, IT IS POSSIBLE THAT CALCIFICATION CAUSED SURFACE ABRASIONS ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM THRILL PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0906092

    Patients

    Seq Age Sex Outcome Treatment
    1 YR SHEATH INTRODUCER (5F/BRAND: UNKNOWN)| GUIDEWIRE(AQUA/ASAHI INTECC)