BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO RELY SP 3.0/20MM BALLOON CATHETER

    MDR report key: 224000 · Received May 13, 1999

    Report

    Report Number
    1220452-1999-00026
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Report Date
    April 30, 1999
    Manufacturer
    MEDTRONIC VASCULAR INC.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING PREP, WHILE THE PHYSICIAN ATTEMPTED TO FLUSH THE LUMEN OF THIS DEVICE, REPORTEDLY CONTRAST LEAKED THROUGH A HOLE IN THE SHAFT. THERE WAS NO PT INVOLVEMENT AND THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOLLO RELY SP 3.0/20MM BALLOON CATHETER BALLOON CATHETERS LOX MEDTRONIC VASCULAR INC. NA 44FIB296

    Patients

    Seq Age Sex Outcome Treatment
    1 NA