BEUDAMED
    FDA Adverse Event Summary report: N

    PTA SAVVY 2.0X4CM 120CM

    MDR report key: 891998 · Received October 13, 2004

    Report

    Report Number
    9610978-2004-01064
    Date Received
    October 13, 2004
    Date of Event
    September 9, 2004
    Report Date
    October 13, 2004
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT REC'D FROM OUR AFFILIATE INDICATED THAT A PTA AT RIGHT VERTEBRAL ARTERY WITHIN RIGHT FEMORAL APPROACH WAS PERFORMED IN 2004. THE LESION WAS CONCENTRIC AND HEAVILY CALCIFIED, SLIGHTLY TORTUOUS WITH 99% STENOSIS. DURING PROCEDURE PT WAS HEPARINIZED WITH 3000 UNITS. THE BALLOON RUPTURED BELOW RATED BURST PRESSURE AT PRE-DILATION (PRESSURE UNK). PROCEDURE WAS COMPLETED WITH COMPETITOR'S PROD (GATEWAY/BSJ). THERE WAS NO PT INJURY. THIS PROD WILL BE RETURNED FOR EVAL AND TESTING. ADD'L INFO WILL BE SENT WITHIN 30 DAY UPON RECEIPT.

    Description of Event or Problem · 1

    BALLOON RUPTURE. IS NOT ON FILE FOR TEXT COPY. ENTER TEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTA SAVVY 2.0X4CM 120CM PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R1102437

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GATEWAY BALLOON| SV GUIDEWIRE| 7F SHUTTLE SHEATH