BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1023553 · Received March 31, 2008

    Report

    Report Number
    9610978-2008-00086
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICALLY USED SAVVY BALLOON CATHETER WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. MICROSCOPIC EXAMINATION OF THE CATHETER REVEALED NO ANOMALIES. FUNCTIONAL TESTING WAS PERFORMED BY PRESSURIZING THE BALLOON TO 6 ATMOSPHERES. A NEGATIVE PRESSURE WAS THEN APPLIED TO THE BALLOON TO DEFLATE IT. THE BALLOON DEFLATED IMMEDIATELY AND WITHOUT DIFFICULTY. NO ANOMALIES WERE OBSERVED. REPEATED TESTING OF THIS TYPE REVEALED NO FUNCTIONAL DIFFICULTIES. THE REPORTED DEFLATION DIFFICULTY WAS NOT CONFIRMED. BASED ON THE INFO AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    DURING DEFLATION OF THE BALLOON IN THE COMMON CAROTID ARTERY, THE PHYSICIAN NOTED THAT BALLOON SEEMED TO DEFLATE SLOWLY. THE PHYSICIAN RE-INFLATED THE BALLOON TO NOMINAL PRESSURE, AND AGAIN DEFLATED IT, THIS TIME WITHOUT DELAY OR DIFFICULTY. THERE WAS NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R1106065

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK