BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 5222960 · Received November 13, 2015

    Report

    Report Number
    1220452-2015-00054
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 16, 2015
    Report Date
    November 13, 2015
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQO
    PMA / PMN Number
    K884065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RECEIVED FOR ANALYSIS WAS ONE PWP BALLOON CATHETER WITH WHAT APPEARED TO BE BLOOD ON THE BALLOON. A SYRINGE WAS RECEIVED CONNECTED TO THE RED SIDE LEG. CATHETER AS RECEIVED HAS NO VISIBLE KINKS OR CRUSH OR ANY OTHER DAMAGE. INITIAL INFLATION TESTING CONDUCTED ON THE BALLOON USING THE RETURNED SYRINGE WAS SUCCESSFUL. THE BALLOON WAS SYMMETRICALLY FORMED AS REQUIRED. THE BALLOON ALSO MAINTAINED INFLATION WITHOUT LEAKING. PHYSICAL MEASUREMENTS SHOW THE DEVICE MEETS SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED AND ALL RELEVANT TESTING FOR THE RETURNED DEVICE PASSED PWP CATHETER PERFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A PWP CATHETER DURING A RIGHT HEART DIAGNOSTIC PROCEDURE. THE DEVICE WAS INSPECTED AND TESTED PRIOR TO THE PROCEDURE WITH NO ISSUES NOTED. DURING THE PROCEDURE THE PWP CATHETER WAS PROVIDING INACCURATE PRESSURE READINGS. EXTRA CLOTTING WAS ALSO REPORTED, AS WELL AS A LOW PRESSURE WAVE. IT WOULDN'T REGISTER PRESSURE AND IT WAS CLOTTING OFF PREMATURELY. THE EXTRA CLOTTING WAS ASSESSED FROM THE LACK OF PRESSURE READINGS. THE PATIENT WAS NOT HEPARINIZED. THE SYRINGE THAT COMES WITH THE PWP WAS USED AS THE INFLATION DEVICE. A NEW PWP WAS THEN USED. THE NEW SYRINGE THAT CAME WITH THE NEW PWP WAS THEN USED FOR INFLATION, AND THE CATHETER WORKED FINE. NO INTERVENTION WAS REQUIRED. THE PATIENT WAS FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753614 PWP CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MEDTRONIC, INC 0007627204

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR