BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC

    MDR report key: 7276373 · Received February 16, 2018

    Report

    Report Number
    2029214-2018-00113
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    January 22, 2018
    Report Date
    April 20, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    DQY
    PMA / PMN Number
    K150107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE FOR THE COMPLETED INVESTIGATION: THE ARC CATHETER WAS RETURNED FOR ANALYSIS AND THE ARC WAS MEASURING AND FOUND THAT APPROXIMATELY 13.0CM OF THE ARC DISTAL END WAS FOUND TO BE SEPARATED AND MISSING. IT WAS REPORTED THE SEPARATED ARC CATHETER SEGMENT WAS REMOVED FROM WITHIN THE PATIENT; HOWEVER, WAS NOT RETURNED AND THE REASON NOT PROVIDED. UPON VISUAL INSPECTION, NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE ARC CATHETER HUB. THE ARC CATHETER SHAFT WAS FOUND TO BE KINKED AND BUCKLED NEAR THE DISTAL END. THE OUTER TUBING MATERIAL OF THE ARC CATHETER SEPARATED END EXHIBITED WITH PLASTIC DEFORMATION (STRETCHING WITH JAGGED EDGES). THE INNER WIRE WAS FOUND TO BE STRETCHED AND SEPARATED. THE INNER LINER WAS FOUND TO BE TWISTED AND PROTRUDING FROM WITHIN THE SEPARATED END FOR APPROXIMATELY 10.5CM. THE DISTAL END OF THE INNER LINER APPEARS TO BE SMOOTH AND EVEN. THE INNER LINER DOES NOT APPEAR TO HAVE SEPARATED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO FLUSH THE ARC CATHETER AS THE WATER COULD NOT EXIT THE TWISTED SECTION OF THE INNER LINER. NO OTHER ANOMALIES WERE OBSERVED. THE ARC CATHETER WAS USED OFF-LABEL DURING AN ASPIRATION PROCEDURE TO TREAT A STROKE. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER SEPARATION/BREAK¿ WAS CONFIRMED AS THE ARC CATHETER WAS RETURNED SEPARATED. THE BROKEN END OF THE RETURNED ARC CATHETER EXHIBITED WITH PLASTIC DEFORMATION (STRETCHING AND JAGGED EDGES) WHICH INDICATES THAT THE ARC CATHETER SEPARATED AS THE TENSILE STRENGTH OF THE TUBING MATERIAL WAS EXCEEDED. IT IS POSSIBLE THE PATIENT¿S ¿MODERATE¿ VESSEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT CAUSING THE ARC TO KINK DURING USE SUBSEQUENTLY CAUSING THE CATHETER TO SEPARATE DURING REMOVAL. HOWEVER, THE CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. IN ADDITION, ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THEREFORE, MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. PER THE ARC IFU (INSTRUCTIONS FOR USE): ¿THE ARC INTRACRANIAL SUPPORT CATHETER IS INDICATED FOR THE INTRODUCTION OF INTERVENTIONAL DEVICES INTO THE PERIPHERAL AND NEURO VASCULATURE.¿ IN ADDITION, ¿DO NOT ADVANCE OR WITHDRAW THE ARC INTRACRANIAL SUPPORT CATHETER AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF THE CAUSE USING FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW THE DEVICE. MOVING OR TORQUING THE DEVIC E AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VESSEL OR DEVICE. TORQUING THE CATHETER MAY CAUSE DAMAGE WHICH COULD RESULT IN KINKING AND POSSIBLE SEPARATION ALONG THE CATHETER SHAFT. SHOULD THE SYSTEM BECOME SEVERELY KINKED, WITHDRAW THE ENTIRE SYSTEM (ARC INTRACRANIAL SUPPORT CATHETER, GUIDE WIRE AND CATHETER SHEATH INTRODUCER)." IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED. AS THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RECEIVED ADDITIONAL INFORMATION STATING THAT THE CLOT WAS SOFT AND NORMAL AND THAT IT WAS REMOVED BY DIRECT ASPIRATION WITH THE ARC MICROCATHETER. THERE WAS SUCCESSFUL ASPIRATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) WITH TICI 2A. THE MCA WAS REPORTED TO HAVE MINIMAL TORTUOSITY. IT WAS ALSO REPORTED THAT THE SEPARATED ARC SEGMENT WAS REMOVED FROM THE PATIENT USING A SNARE KIT AND NO PIECES REMAIN IN THE PATIENT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE DISTAL PART OF THE INTRACRANIAL SUPPORT CATHETER DETACHED INSIDE THE CERVICAL INTERNAL CAROTID ARTERY (ICA), AS THE CATHETER WAS BEING RETRIEVED. THIS EVENT OCCURRED DURING A MECHANICAL ASPIRATION STROKE CASE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122082 ARC CATHETER, PERCUTANEOUS DQY COVIDIEN (IRVINE) ARC-132 A212664

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention| S