BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTI

    MDR report key: 20309175 · Received September 26, 2024

    Report

    Report Number
    9616099-2024-00322
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 21, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    DRE
    UDI-DI
    10705032010054
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE SIDE PORT OF A 6F AVANTI PLUS CATHETER SHEATH INTRODUCER WAS BLOCKED BY CLOT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE REPORTED ¿SIDE PORT EXTENSION OBSTRUCTED PARTICLES/MATERIAL CAN BE INJECTED¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. FACTORS SUCH AS VESSEL ANATOMY, USER HANDLING, AND CONCOMITANT DEVICES COULD BE A CONTRIBUTING FACTOR ADDITIONAL FORCE AND MANIPULATION OF THE CATHETER SHEATH INTRODUCER (CSI) WHILE IN THE VESSEL MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR THE REPORTED EVENT. IF THE CSI IS NOT FLUSHED PROPERLY WITH HEPARINIZED SALINE OR A SUITABLE ISOTONIC SOLUTION AS PER THE INSTRUCTIONS FOR USE (IFU), BLOOD FLOW CAN CLOT. IN ADDITION, PATIENT FACTORS (WHICH WERE NOT SPECIFIED), SUCH AS COMORBIDITIES AND HYPERCOAGULABILITY COULD HAVE ATTRIBUTED. AS PER THE INSTRUCTIONS FOR USE (IFU), ONCE THE SIDEPORT HAS BEEN ASPIRATED TO REMOVE AIR, IT SHOULD BE CONSIDERED TO ESTABLISH A HEPARINIZED SALINE OR SUITABLE ISOTONIC SOLUTION VIA THE SIDEPORT EXTENSION. THE ADDITION OF A HEPARINIZED SALINE VIA THE SIDE PORT EXTENSION CAN HELP WITH THE PREVENTION OF THROMBUS FORMATION. THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED AS ANTICIPATED.

    Description of Event or Problem · 0

    AS REPORTED, THE SIDE PORT OF A 6F AVANTI PLUS CATHETER SHEATH INTRODUCER WAS BLOCKED BY CLOT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248282 AVANTI DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE 18333205 10705032010054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.