BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 14437231 · Received May 19, 2022

    Report

    Report Number
    2134243-2022-00009
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 19, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    OBI
    UDI-DI
    30841916102272
    PMA / PMN Number
    K190473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVVUS CATHETER, LOT NUMBER 0000185531, IS BEING DELIVERED FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Additional Manufacturer Narrative · 0

    CORRECTION FOR INITIAL MEDWATCH MADE TO FIELD H5. DEVICE IS LABELED FOR SINGLE USE. ON JULY 8, 2022, THE ACIST NAVVUS II CATHETER WAS INVESTIGATED. THE CATHETER WAS SEPARATED 34CM FROM THE DISTAL TIP. THIS CONFIRMED THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO DEVIATIONS TO THE SPECIFICATION OR MANUFACTURING PROCESS WERE PRESENT DURING MANUFACTURING. ON JULY 7, 2022 THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: DIAGNOSTIC IMAGES WERE OBTAINED FROM THE ARM ACCESS AND SUBSEQUENTLY FROM THE LEFT COMMON FEMORAL. INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY, AND A BALLOON WAS USED DURING THE PROCEDURE. THE ACIST NAVVUS II CATHETER WAS USED TO MEASURE THE GRADIENTS. THE NAVVUS II CATHETER FRACTURED WHEN CROSSING THE AIB. THE IMAGES SHOW THE DISTAL END OF THE CATHETER BEING REMOVED WITH A SNARE. A MILD TYPE 1 DISSECTION ALONG THE ANGIOPLASTY SITE WAS SEEN AND IS NOTED TO BE TYPICAL WITH THIS TYPE OF INTERVENTION. THIS TYPE OF DISSECTION DOES NOT REPRESENT A FAILURE OF THE NAVVUS II CATHETER OR A COMPLICATION OF THE INTERVENTION.

    Description of Event or Problem · 0

    DURING THE THIRD TRIAL, USING THE ACIST RXI AND NAVVUS CATHETER, THE USER ATTEMPTED TO MEASURE THE DISTAL RESIDUAL LESION OF THE TARGET, THERE WAS RESISTANCE, AND THE CATHETER COULD NOT CROSS. THE RXI SYSTEM DISPLAYED A WARNING MESSAGE AND THE NAVVUS WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE NAVVUS CATHETER, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN. THE PIECE OF CATHETER REMAINING WITHIN THE PATIENT'S VASCULATURE WAS COLLECTED WITH A SNARE WIRE. A NEW NAVVUS CATHETER WAS USED AND THE LESION WAS CROSSED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THE NAVVUS CATHETER WAS BROKEN AT THE LOCATION OF THE CURVE CROSSING THE COMMON ILIAC ARTERY BIFURCATION. THE VESSEL WAS NOT TORTUOUS AND DID NOT CREATE ANY TENSION. THE PHYSICIAN COMMENTED THAT THE CATHETER BREAK WAS LIKELY CAUSED WHEN MOVING THROUGH A HAIRPIN-LIKE CURVE WITHIN THE VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977152 ACIST CATHETER, PRESSURE MONITORING, CARDIAC, OBI OBI ACIST MEDICAL SYSTEMS, INC. NAVVUS II 0000185531 30841916102272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention MEDICON LUTONIX DCB 6.0MMX120MM.| MEDTRONIC CHOCOLATE PTA BALLOON 5.00MMX120MM.| NIPRO CROSSROADS 6FR.