BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5973979 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00004
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SEQUENT MEDICAL INC.
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Removal / Correction Number
    SEEBOX 10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 0000000-09/XX/2016-001-R. TO BE UPDATED WHEN THE REPORTING NUMBER HAS BEEN FINALIZED.

    Description of Event or Problem · 1

    RE-CANALIZED DISTAL ICA ANEURYSM, TRI-AXIAL SYSTEM. DIFFICULT ANATOMY PER THE PHYSICIAN, "FLATTENED ANTERIOR GENU." THE PHYSICIAN ADVANCED THE PIPEFLEX THROUGH THE VIA-27 AND BEGAN UNSHEATHING THE PIPEFLEX. THE PHYSICIAN WANTED TO RE-SHEATH PIPEFLEX TO REPOSITION IT BUT WAS NOT SUCCESSFUL AND MENTIONED THAT VISIBLE TENSION WAS BUILT UP IN THE MICRO CATHETER. THE PHYSICIAN PULLED BACK THE CATALYST 5 INTRACRANIAL GUIDE TO HELP RELEASE THE TENSION. ALTHOUGH THE PIPEFLEX COULD NOT BE RE-SHEATHED INTO THE VIA 27, THE PHYSICIAN SUCCESSFULLY FINISHED DEPLOYMENT AT THE NECK OF THE ANEURYSM AND OBTAINED GOOD WALL OPPOSITION. THE PHYSICIAN COMMENTED THAT THE DEVICE WAS WELL OPPOSED TO THE ARTERY WALL. THE PHYSICIAN TRIED TO RE-ADVANCE THE VIA-27 THROUGH THE DEPLOYED DEVICE TO CAPTURE/COVER THE END OF THE GUIDE WIRE BEFORE PULLING THE DELIVERY WIRE THROUGH THE FLOW DIVERTER, BUT WAS UNABLE TO ADVANCE AND COMPLETE THAT MOVEMENT. THE PHYSICIAN WITHDREW THE DELIVERY WIRE THROUGH THE PIPEFLEX AND THEN WITHDREW THE VIA-27 OUT OF THE BODY. THE PHYSICIAN COMMENTED ON THE LOOK (APPEARED STRETCHED) OF THE VIA-27 NEAR THE DISTAL TIP. THE PHYSICIAN REPORTS THERE IS NO DEFICIT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624846 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 15112003

    Patients

    Seq Age Sex Outcome Treatment
    1 .016 GUIDEWIRE| CATALYST 5 INTRACRANIAL GUIDE CATHETER| NEURONMAX 6F SHEATH| PIPEFLEX 3.75X14