BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 8925700 · Received August 23, 2019

    Report

    Report Number
    1220452-2019-00101
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    September 20, 2017
    Report Date
    August 23, 2019
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    UDI-DI
    00613994821089
    PMA / PMN Number
    K132673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: RECEIVED FOR ANALYSIS WAS ONE LA6IMA 6F LAUNCHER GUIDE CATHETER WITH ORIGINAL PACKAGING, THE POUCH FOR LOT NUMBER 0007786212 WAS RECEIVED. THE BOX AND THE DIE CARD WERE NOT RETURNED. THE CATHETER EXHIBITED TWO KINKS: 2CM AND 3CM FROM THE TIP. AS RECEIVED THE CATHETER EXHIBITED SOME BLOOD-LIKE STAINS ON THE STRAIN RELIEF NEAR THE HUB. SOME PIECES OF THE WHITE TIP REMAINED ON THE EDGES OF THE DISTAL SHAFT, THE BLUE INNER LAYER APPEARS STRETCHED LIKELY INDICATING PULL FORCE APPLIED TO THE TIP. BRAID WIRE AT THE EDGE OF THE DISTAL END OF THE SHAFT ALSO APPEARED DISLODGED. PIECES OR THE REMAINING PARTS OF THE TIP WERE NOT RETURNED FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A LA6IMA LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. IT IS REPORTED THAT THE CATHETER TIP COMPLETELY DETACHED WHEN INSERTING IT INTO THE 6F NON-MDT SHEATH. THE TIP OF A SECOND CATHETER WAS THEN CHECKED AND WHEN GENTLY PRESSED THE TIP COMPLETELY DETACHED FROM THE CATHETER. NO PATIENT INJURY IS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LAUNCHER OF THE SAME SIZE. AT THE FACILITY THE CATHETERS ARE STORED IN THE NURSE'S ROOM IN A CLOSED CABINET, HANGING WITH RESTRICTED ACCESS. THERE IS A WINDOW IN THE ROOM BUT THE CATHETERS ARE NOT EXPOSED TO LIGHT SINCE THE CABINET IS CLOSED WITH WOODEN DOORS. THE CATHETERS ARE REMOVED FROM THE BOXES AND LEFT HANGING. THE ROOM TEMPERATURE IS APPROXIMATELY 20 DEGREES. ALTHOUGH IT WAS REPORTED THAT THE DEVICES WERE NOT USED IN THE PATIENT THE DAMAGE OBSERVED INDICATES THAT AN ATTEMPT MAY HAVE BEEN MADE TO INSERT THE DEVICES INTO THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717850 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC LA6IMA 0007786212 00613994821089

    Patients

    Seq Age Sex Outcome Treatment
    1