BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 3202581 · Received July 2, 2013

    Report

    Report Number
    1220452-2013-00034
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    August 19, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K022764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4) BOTH PORTIONS OF THE GUIDE CATHETER WERE RETURNED FOR EVALUATION. INCLUDING THE PIECE THAT WAS SURGERY REMOVED FROM THE PATIENT. NO CINE WAS RETURNED BY CUSTOMER TO AID IN THE INVESTIGATION. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR BROKEN SHAFT. THE GUIDE CATHETER WAS TORQUED UNTIL IT KINKED RESULTING IN THE SHAFT BREAKING. THERE IS NO INDICATION OF A MANUFACTURING OR QUALITY DEFECT. THE INSTRUCTIONS FOR USE (IFU) STATES IF THE GUIDE CATHETER IS TORQUED WHEN KINKED IT MAY CAUSE DAMAGE THAT COULD RESULT IN SEPARATION ALONG THE CATHETER SHAFT. IN THE EVENT THE CATHETER SHAFT BECOMES KINKED, WITHDRAW THE GUIDE CATHETER, GUIDE WIRE AND CATHETER SHEATH INTRODUCER. IT APPEARS THAT THE GUIDE CATHETER WAS TORQUED BEYOND DESIGN EXPECTATION RESULTING IN THE CATHETER BREAKING. NO FURTHER ACTION TO BE TAKEN AT THIS TIME. THE INVESTIGATION IS COMPLETE AS OF (B)(4) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE AND OR CASE CINE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT AND A FOLLOW-UP MED WATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE GUIDING CATHETER WAS USED IN FEMORAL APPROACH. THE GUIDING CATHETER WAS FRACTURED DURING REMOVAL FROM THE BODY. THE FRACTURED REMAIN PART LEFT INSIDE THE BODY. THE GUIDING WAS FOUND KINKED. AND THE KINKED PART WAS GOT LOCKED WITH THE SHEATH INSIDE THE BODY (FEMORAL) AND IT WAS BROKEN DUE TO THAT. THE DISTAL END IS STILL NEAR THE AORTA. ADDITIONAL INFORMATION RECEIVED NOTHING LEFT NOW, PATIENT IS STABLE. HE HAD THE CARDIAC SURGERY. PHYSICIAN WILL LOOK IT UP AND SEND US THE CD

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE GUIDING CATHETER WAS USED IN FEMORAL APPROACH. THE GUIDING CATHETER WAS FRACTURED DURING REMOVAL FROM THE BODY. THE FRACTURED REMAIN PART LEFT INSIDE THE BODY. THE GUIDING WAS FOUND KINKED. AND THE KINKED PART WAS GOT LOCKED WITH THE SHEATH INSIDE THE BODY (FEMORAL) AND IT WAS BROKEN DUE TO THAT. THE DISTAL END IS STILL NEAR THE AORTA. ADDITIONAL INFORMATION PROVIDED, REVEALED THE PORTION THAT BROKE IN THE PATIENT WAS REMOVED IN CARDIAC SURGERY AND NOTHING REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301123 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTORNIC, INC 0006552195

    Patients

    Seq Age Sex Outcome Treatment
    1