BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STINGRAY

    MDR report key: 2497632 · Received February 27, 2012

    Report

    Report Number
    2497632
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 27, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INFLATING A STINGRAY BALLOON AT 3 ATM OF PRESSURE THE BALLOON RUPTURED. THREE ATM IS RECOMMENDED PRESSURE BY FDA. NO KNOWN INJURY TO PATIENT.======================MANUFACTURER RESPONSE FOR CARDIAC BALLOON CATHETER, STINGRAY ORIENTATING BALLOON CATHETER 6 FR 2 MM (PER SITE REPORTER).======================PLAN TO RELEASE TO MANUFACTURER WITH PROMISE TO SHARE RESULTS OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STINGRAY CATHETER, PERCUTATEOUS DQY BRIDGEPOINT MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR