BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI MICROCATHETER 18L

    MDR report key: 1321594 · Received February 19, 2009

    Report

    Report Number
    2954917-2009-00005
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    November 20, 2008
    Report Date
    February 17, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K003086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS VESSEL DISSECTION AND PERFORATION AS POSSIBLE PROCEDURAL COMPLICATIONS. ALSO, THERE IS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO PREVENT VESSEL DAMAGE.

    Description of Event or Problem · 1

    THIS EVENT WAS ORIGINALLY REPORTED TO A CONCENTRIC EMPLOYEE IN 2008, BUT IT WAS NOT UNTIL 2009, WHEN WE HAD ENOUGH INFORMATION TO DETERMINE THE EVENT MET FDA 30 DAY MEDICAL DEVICE REPORT CRITERIA. PATIENT HAD MCA OCCLUSION FROM A RECENT HEART CATHETERIZATION. THE ICA WAS TORTUOUS AND PATIENT HAD VASCULAR DISEASE THROUGHOUT ENTIRE ARTERIAL SYSTEM. THE PHYSICIAN USED A RETRIEVER V 2.5 SOFT, MICROCATHETER MC18L (WITH BOSTON SCIENTIFIC FATHOM 0.016" STEERABLE GUIDEWIRE) AND DISTAL ACCESS CATHETER (DAC). HE CHOSE TO NOT ADVANCE THE DAC PAST THE CAVERNOUS PORTION OF THE ICA DUE TO AN ATHEROMA THAT HE DID NOT WANT TO EMBOLIZE. UPON DEPLOYMENT OF THE RETRIEVER, HE NOTICED THAT THE MC18L TIP STARTED TO MOVE PROXIMALLY (IN HIS WORDS IT "JUMPED BACK"). HE COMPLETED THIS FIRST RETRIEVAL ATTEMPT UNSUCCESSFULLY (CLOT WAS EXTREMELY WELL LODGED IN VESSEL). HE THEN RAN THE MC18L AND FATHOM 0.016" WIRE PAST THE CLOT TO PREPARE FOR A SECOND RETRIEVAL ATTEMPT. HE NOTICED THAT UPON DISTAL INJECTION THROUGH THE MC18L, THERE WAS CONTRAST MEDIA BLUSH, INDICATING A VESSEL PERFORATION. THE PHYSICIAN WAS NOT SURE IF THE CONTRAST BLUSH WAS DUE TO THE FATHOM 0.016" GUIDEWIRE, THE MC18L OR THE V 2.5 SOFT RETRIEVER. UPON DEPLOYMENT OF THE RETRIEVER L4 (NEW DEVICE), HE NOTICED THAT THE MC18L TIP STARTED TO "JUMP BACK" AGAIN. HE WAS WONDERING IF THE DAC MADE THE MC18L MORE UNSTABLE BECAUSE HE HAD IT AT THE CAVERNOUS CAROTID. END RESULT, HE STOPPED THE SECOND PASS DUE TO THE RIGIDITY OF THE CLOT. IN 2008, THE PHYSICIAN SAID HE WAS GOING TO LOOK OVER THE CASE AGAIN AND CALL IF HE THOUGHT IT WAS TRULY RELATED TO OUR DEVICES. IN 2009, WE RECEIVED FEEDBACK FROM THE PHYSICIAN INDICATING THAT HE WAS CONCERNED THAT THE DAC CAUSED THE MC18L TO "JUMP BACK" AND PERFORATE THE MCA. NONE OF THE REPORTED INFORMATION SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other