BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 8507329 · Received April 11, 2019

    Report

    Report Number
    2134243-2019-00005
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 12, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBERS: ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 33218Z, ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 00219F, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P65, LOT 35518P. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4) WAS RETURNED TO ACIST ON MARCH 27, 2019. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTION SYSTEM. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE USE OF THE DEVICE. THE CONSUMABLE KITS WERE DISCARDED BY THE USER FACILITY; THE LOTS NUMBERS OF THE CONSUMABLE KITS WERE PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED ON APRIL 30, 2019, FOR THE FOLLOWING CVI CONSUMABLE KIT LOTS USED DURING THE EVENT: ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 33218Z, ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 00219F, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P65, LOT 35518P. THIS REVIEW CONFIRMED THAT THERE WERE NO MANUFACTURING QUALITY ISSUES FOR THESE LOTS RELATED TO THE REPORTED EVENT. BASED ON TESTING AND EVALUATION OF THIS CVI INJECTION SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RECEIVED AT ACIST ON MARCH 27, 2019. INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT A FOLLOWUP REPORT TO FDA.

    Description of Event or Problem · 1

    DURING A STENT PLACEMENT TO OSTIAL/PROXIMAL LEFT SUBCLAVIAN ARTERY, USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, WITH BALLOON PLACED WITHIN THE PATIENT'S SUBCLAVIAN LEFT ARTERY, THE CVI INJECTION SYSTEM BEGAN TO REPEATEDLY PERFORM A PURGE OF CONTRAST MEDIA. THE BALLOON REMAINED UNINFLATED, WITH THE STENT IN AN UNDEPLOYED STATE AS THE USERS PERFORMED TROUBLESHOOTING STEPS TO RESOLVE THE REPEATED PURGING WITH THE CVI INJECTION SYSTEM. THE PATIENT'S BLOOD FLOW WAS INTERRUPTED DUE TO THE BALLOON REMAINING WITHIN THE ARTERY DURING THE TROUBLESHOOTING AND THE PATIENT DEVELOPED SYMPTOMS CONSISTENT WITH A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT'S SYMPTOMS SUBSEQUENTLY RESOLVED AS CONFIRMED BY NEUROLOGICAL ASSESSMENT. THE PROCEDURE WAS RESUMED; THE BALLOON WAS REINFLATED AN ADDITIONAL TWO TIMES. POST-PROCEDURE, NEUROLOGICAL ASSESSMENT CONFIRMED THE PATIENT HAD RETURNED TO BASELINE WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300345 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening ANCEF| ASPIRIN| FENTANYL| HEPARIN| ISOVUE 250| OXYGEN| SALINE DRIP| ANCEF| ASPIRIN| FENTANYL| HEPARIN| ISOVUE 250| OXYGEN| SALINE DRIP