BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 2945243 · Received February 6, 2013

    Report

    Report Number
    1220452-2013-00009
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 10, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BREAK THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD DETECTS NO ISSUES RELATED TO OR THAT WOULD RESULT IN THE REPORTED EVENT. THERE ARE NO PRIOR COMPLAINTS OF ANY TYPE FOR THIS LOT. IF IN THE FUTURE ANY ADDITIONAL INFORMATION OR THE ACTUAL COMPLAINT SAMPLE IS RETURNED A FOLLOW-UP MED WATCH WILL BE SUBMITTED. THE EVENT IS NOT CONFIRMED DUE TO NO PRODUCT RETURNED. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO US DURING RIGHT RADIAL APPROACH AL 1.0 GUIDER WAS INSERTED INTO CENTRAL AORTA. DUE TO TORTUOSITY AND TORQUING OF THE CATHETER, GUIDER KINKED AT TIP OF SHEATH AND WAS UNABLE TO PASS WIRE THRU CATHETER. ATTEMPT TO REMOVE VIA RADIAL SHEATH UNSUCCESSFUL, AND GUIDER SEVERED WITH 70 CM REMAINING EXTENDING FROM DISTAL SHEATH TIP TO INNOMINATE ARTERY. FEMORAL ARTERIAL PUNCTURE DONE AND INTERVENTION WAS COMPLETE VIA FEMORAL ACCESS. AT END OF CASE, RADIAL SHEATH REMOVED BUT GUIDE REMAINED LOGGED AT RADIAL ARTERIOTOMY SITE WITH SHEARED END OUTSIDE OF ARTERY IN SUBCUTANEOUS TISSUE. UNDER X-RAY, THE END OF THE CATHETER IN THE SUB Q TISSUE WAS GRABBED UNDER FLUOROSCOPY AND REMAINING LENGTH OF GUIDE REMOVED INTACT THROUGH ACCESS SITE. PRESSURE DEVICE PLACED WITH GOOD HOMEOSTASIS AT ACCESS SITE. IT WAS A VERY DIFFICULT CASE, BECAUSE OF THE ANATOMY. THE GUIDE CATHETER WAS DISCARDED, THE PATIENT IS DOING FINE AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50981 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTORNIC, INC 0006329040

    Patients

    Seq Age Sex Outcome Treatment
    1