BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRION QL38 LOCKING SYRINGE

    MDR report key: 3231330 · Received July 15, 2013

    Report

    Report Number
    1043729-2013-00001
    Event Type
    Death
    Date Received
    July 15, 2013
    Date of Event
    April 11, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Product Code
    MAV
    PMA / PMN Number
    K060643
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DELAY IN MDR REPORTING WAS DUE TO LACK OF CLARITY IN THE INITIAL INFORMATION RECEIVED FROM THE FIELD REGARDING THE DEVICE'S ALLEGED CONTRIBUTION TO THE ADVERSE EVENT. THERE WERE DELAYS IN GETTING COMPLETE INFORMATION FROM THE (B)(6) HOSPITAL AND CONFUSION REGARDING THE FACTS REGARDING THE EVENT. UPDATED INFORMATION WAS RECEIVED ON (B)(4) 2013, WHICH MADE THE REQUIREMENT TO REPORT CLEAR. CAPA NUMBER (B)(4) HAS BEEN OPENED INTERNALLY TO ADDRESS THIS DELAY. EVALUATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD FOR THE COMPLAINT LOT INDICATED THE DEVICE WAS MANUFACTURED UNDER NORMAL OPERATING CONDITIONS. THE LOT WAS SAMPLED, INSPECTED, AND ACCEPTED PER WORK INSTRUCTION 91140, FINISHED PRODUCT INSPECTION - INFLATION DEVICES. DURING THE LIFE OF THE PRODUCT, (B)(4) UNITS HAVE BEEN SHIPPED AND THIS IS THE ONLY KNOWN INCIDENT WHERE FLUID BEHIND THE PLUNGER HAS BEEN REPORTED TO BE RELATED TO AN ADVERSE OUTCOME. INVESTIGATION OF FAILED UNIT: THE COMPLAINT DEVICE WAS EVALUATED BY CUSTOMER PRIOR TO ITS RETURN TO MANUFACTURER. ONCE THE DEVICE WAS RECEIVED BY MANUFACTURER, IT WAS VISUALLY INSPECTED FOR ANOMALIES. FLUID WAS AGAIN OBSERVED BETWEEN THE LIPS OF THE SEAL. THE DEVICE WAS PUMPED MULTIPLE TIMES TO EXPEL THE FLUID BETWEEN THE SEAL LIPS. CONCLUSIONS: THE COMPLAINT DEVICE PERFORMED PER MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A TRANSAORTIC PROCEDURE, THE 26MM SAPIEN XT VALVE MIGRATED IN THE LV (VG). CAUSE: DURING THE DEPLOYMENT OF THE VALVE, THE BALLOON DID NOT COMPLETELY OPEN BECAUSE THERE WAS A LEAK AT THE LEVEL OF THE SYRINGE, ABOUT 4CC LESS, SO THE VALVE WAS NOT IMPACTED AND MIGRATED IN THE LV (VG). RVAO CONVERSION AND AN ECMO WAS PLACED. PATIENT STATUS: HEMODYNAMICALLY UNSTABLE. ANOTHER DELIVERY SYSTEM WAS ALREADY PREPPED, THAT WAS USED TO PULL BACK THE VALVE INTO THE ANNULUS SUCCESSFULLY, HOWEVER, SHE WAS HEMODYNAMICALLY UNSTABLE AND THEY DECIDED TO CONVERT. THE CUSTOMER CLINICAL SPECIALIST (CS) FURTHER CLARIFIED DS BALLOON WAS TESTED AND NO LEAK WAS OBSERVED. BUT DOCTOR OBSERVED THAT HIS GLOVES WERE WET AND THAT THERE WAS 4CC LESS IN THE SYRINGE. SALES REP CONFIRMED THAT PER MEDICAL OPINION, THE EVENT WAS RELATED TO THE SYRINGE. ON (B)(6) 2013 CS WAS INFORMED THAT PATIENT DIED ON (B)(6) 2013 (8 DAYS AFTER IMPLANT DATE). IT WAS A VERY FRAGILE PATIENT. CS FURTHER CLARIFIED THAT PER PHONE CALL WITH DOCTOR, THE HVT VALVE HAS NOTHING TO DO WITH THE PATIENT DEATH. PATIENT DEATH WAS RELATED TO PROCEDURAL COMPLICATION AFTER THE THV VALVE EMBOLIZATION DUE TO THE LEAK AT THE MANUFACTURER'S SYRINGE. ON (B)(6), THE PATIENT WAS AWAKEN AND THE ECMO WAS RETIRED, THEN DURING THE NIGHT, THE PATIENT DIED. VISUAL INSPECTION (BY CUSTOMER) REVEALED FLUID BEHIND THE SEAL (LESS THAN 4CC). ASCENDRA + DELIVERY SYSTEM WAS ATTEMPTED TO BE INFLATED, BUT EVIDENT LEAK OBSERVED COMING FROM BALLOON PORT/ EXTENSION TUBE CONNECTION. EXTENSION TUBE WAS REMOVED AND CRACK OBSERVED ON Y-CONNECTOR BALLOON PORT (NON-MANUFACTURER'S COMPONENT). CUSTOMER IS UNSURE IF THIS OCCURRED DURING CASE OR UPON SHIPPING BACK. SALES REP FURTHER CLARIFIED WITH HOSPITAL TEAM THAT THERE WERE NO DIFFICULTIES DE-AIRING THE DELIVERY SYSTEM DURING PREP, NO LEAKS WERE OBSERVED. WHEN DOCTOR OBSERVED THAT HIS GLOVES WERE WET, WHEN BALLOON WAS TESTED WITH SYRINGE, DOCTOR WAS HOLDING JUST THE SYRINGE WHEN HE FELT THE FLUID. NO "SLAMMING" OF THE PLUNGER OCCURRED DURING THIS CASE. THE DEVICES WERE FLUSHED/ CLEANED WITH HEPARINIZED SALINE PRIOR TO SHIPPING BACK TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325674 ATRION QL38 LOCKING SYRINGE MAV ATRION MEDICAL PRODUCTS, INC. 96406015

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R