BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER STEERABLE DELIVERY SHEATH

    MDR report key: 16976333 · Received May 22, 2023

    Report

    Report Number
    2135147-2023-02242
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 19, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    05415067036025
    PMA / PMN Number
    K212026
    Removal / Correction Number
    2135147-6/8/23-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF SUSPECTED AIR INGRESS THROUGH THE SHEATH CAUSING BUBBLE IN RIGHT CORONARY ARTERY (RCA) RESULTING IN TEMPORARY HYPOTENSION AND BRADYCARDIA WAS REPORTED. THE INVESTIGATION FOUND THE SHEATH WAS NOTED TO HAVE A KINK TO BE PRESENT IN THE EXTENSION TUBING, POSSIBLE DUE TO SHIPMENT OR STORAGE CONDITIONS. THE TIP OF THE SHEATH WAS ABLE TO BE ACTUATED WITH EASE. NO OTHER ANOMALIES WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. ABBOTT IS ISSUING THIS IMPORTANT FIELD SAFETY CORRECTIVE ACTION FOR THE AMPLATZER STEERABLE DELIVERY SHEATH (ASDS) DUE TO THE AIR INGRESS TREND. ABBOTT HAS IDENTIFIED AIR INGRESS AS A POTENTIAL ILLNESS OR INJURY. THE CAPA (ACTION 132620) INVESTIGATION HAS CONFIRMED THAT THE ASDS INTEGRATED HEMOSTASIS VALVE DESIGN AND PROCEDURAL USE ALLOW FOR AIR TO INGRESS WHEN OPTIMAL AIR MANAGEMENT TECHNIQUES ARE NOT ADHERED TO BY PHYSICIANS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6)2023, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS SELECTED TO IMPLANT A DEVICE. DURING THE PROCEDURE, THERE WAS SUSPECTED AIR INGRESS THROUGH THE SHEATH CAUSING BUBBLE IN RIGHT CORONARY ARTERY (RCA) RESULTING IN TEMPORARY HYPOTENSION AND BRADYCARDIA, PATIENT RECOVERED WITH MEDICATION. THE DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829253 AMPLATZER STEERABLE DELIVERY SHEATH CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL ASDS-14F-075 8533920 05415067036025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention