BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F (EBU3.5)

    MDR report key: 1395648 · Received March 30, 2009

    Report

    Report Number
    1220452-2009-00015
    Event Type
    Malfunction
    Date Received
    March 30, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 19, 2009
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE THE PATIENT SUFFERED CARDIAC ARREST. THE GUIDE CATHETER WAS INSERTED INTO THE PATIENT AND ADVANCED INTO THE LESION. THE PHYSICIAN INSERTED A GUIDE WIRE THROUGH THE GUIDE CATHETER AND CROSSED THE LESION. THE PHYSICIAN INSERTED AN IVUS CATHETER HOWEVER, FELT RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE PHYSICIAN CONTINUED THE CASE AND WAS ABLE TO PERFORM INTERVENTION ON THE VESSEL. THE PHYSICIAN REMOVED THE IVUS CATHETER AND THEN INSERTED A STENT DELIVERY CATHETER AND AGAIN FELT RESISTANCE WITH THE GUIDE CATHETER. THE PHYSICIAN CONTINUED THE CASE PLACING STENTS AND DILATATION BALLOON; HOWEVER STILL FEELING RESISTANCE INSIDE THE GUIDE CATHETER. THE PHYSICIAN DURING THE LAST STENT PLACEMENT, THE STENT SYSTEM BECAME LODGED INSIDE THE GUIDE CATHETER RESULTING IN ALL DEVICES HAVING TO BE REMOVED TOGETHER. AT THIS TIME THE PATIENT'S BLOOD PRESSURE DECREASED AND THE PATIENT SUFFERED CARDIAC ARREST. THE PHYSICIAN PERFORMED CARDIAC MASSAGE AND A BALLOON PUMP WAS INSERTED INTO THE PATIENT AND INTUBATION WAS PERFORMED AND THEN THE PATIENT'S BLOOD PRESSURE STABILIZED. THE PHYSICIAN CONTINUED THE CASE WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUNCHER 6F (EBU3.5) DQY MEDTRONIC VASCULAR NA 0000934768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA