BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISITE ARTERIAL CANNULA

    MDR report key: 1890040 · Received November 3, 2010

    Report

    Report Number
    3008500478-2010-00003
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ALLEGEDLY THE PATIENT LOST 3 LITERS OF BLOOD AS A RESULT OF THE REPORTED HOLE IN THE CANNULA. ALTHOUGH THE PRODUCT WAS USED OFF-LABEL THIS IS A SERIOUS INJURY RELATED TO THE USE OF THE DEVICE AND THEREFORE REPORTABLE. THE HOLE THAT CAUSED THE INJURY IF IT HAD BEEN PRESENT AT INSERTION WOULD HAVE BEEN DETECTED. THEREFORE IT CAN BE CONCLUDED THAT THE HOLE DEVELOPED DURING USE. THIS PRODUCT IS INDICATED FOR USE 6 HOURS OR LESS AND IN THIS CASE WAS USED APPROX 18 HOURS. LOT NUMBER WAS UNKNOWN THEREFORE A DHR REVIEW COULD NOT BE PERFORMED. EVALUATION RESULTS: REPORTED DEFECT OF "A LEAK OF THE CANNULA BETWEEN FLEXIBLE SHAFT AND CONNECTOR" WAS CONFIRMED. RECEIVED 1 ARTERIAL CANNULA, MODEL OPTI20. BLOOD WAS VISIBLE THROUGHOUT CANNULA BODY. CANNULA BODY WAS PINCHED NEAR THE OVERMOLD AREA (BETWEEN PROXIMAL NON-WIRE AND DISTAL WIRE REINFORCED SECTIONS). LEAKAGE WAS ALSO NOTED FROM THE EDGE OF OVERMOLD AREA. LEAKAGE OCCURRED FROM TWO ADJACENT TEARS. THE LARGER TEAR WAS APPROXIMATELY 4MM AND THE SMALLER ONE WAS APPROXIMATELY 1MM IN LENGTH. THE UNIT HAS BEEN SENT TO THE MANUFACTURER IN (B)(4) FOR FURTHER INVESTIGATION. ONCE RESULTS ARE RECEIVED THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE OPTI20 DEVICE WAS EVALUATED BY MANUFACTURING ENGINEERING AND QUALITY ENGINEERING AT EDWARDS (B)(4). THE CANNULA BODY WAS PINCHED NEAR THE OVER MOLD AREA AND TEARS AT THE WIRE WOUND SECTION TO OVER MOLD INTERFACE WERE CONFIRMED. THE FOLLOWING RISK CONTROL IS LISTED IN THE INDICATION FOR USE SECTION OF IFU 66346, REV. D: ''THE EDWARDS LIFESCIENCES ARTERIAL PERFUSION CANNULAE ARE INDICATED FOR ARTERIAL PERFUSION IN THE EXTRACORPOREAL CIRCUIT FOR < 6 HOURS.'' THE ROOT CAUSE OF THE LEAK WAS LIKELY OFF-INDICATION USE SINCE THE CANNULA REPORTEDLY LEAKED AFTER USE FOR GREATER THAN 6 HOURS. DATA IS NOT AVAILABLE SUPPORTING THE FLOW INTEGRITY OF CANNULA USED IN THE EXTRACORPOREAL CIRCUIT GREATER THAN 6 HOURS. THE TEARS OBSERVED AT THE OVER MOLD JUNCTION WERE LIKELY CAUSED WHEN THE WIRE WOUND SECTION WAS PINCHED. THE PINCHED AREA IS CONSISTENT WITH CLAMPING AT THE WIRE WOUND SECTION NEAR THE OVER MOLD JUNCTION. THE FOLLOWING RISK CONTROL IS LISTED IN THE DIRECTIONS FOR USE SECTION OF IFU 66346, REV. D: ''FOLLOWING CANNULA PLACEMENT AND INTRODUCER REMOVAL, CANNULA MAY BE CLAMPED IN THE AREA BETWEEN THE WIRE REINFORCEMENT AND THE 3/8" (9.5MM) CONNECTOR.'' FROM (B)(4) 2008 TO DATE, ONE OPTI20 WAS REPORTED LEAKING IN (B)(4) 2009; HOWEVER, THE DEVICE WAS EVALUATED BY THE PRODUCT EVALUATION LAB IN IRVINE AND THE LEAK WAS NOT CONFIRMED. NO REPORTS OF LEAKAGE HAVE BEEN REPORTED WITH OPTI16, OPTI18, OR OPTI22 DEVICES FROM (B)(4) 2008 TO DATE. EACH LOT OF OPTI20 UNDERGOES PULL TESTING (SAMPLING) AND EACH OPTI20 CANNULA IS 100% VISUALLY INSPECTED DURING THE MANUFACTURING PROCESS. THE LOT NUMBER WAS NOT PROVIDED THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE RISK CONTROL MEASURES FOR CANNULA USAGE TIME AND CLAMPING INSTRUCTIONS WITHIN IFU 66346, REV. D ARE STILL APPROPRIATE AND ALL PLANNED ACTIVITIES ASSOCIATED WITH THE MANUFACTURE AND TESTING OF OPTI20 DEVICES ARE ACCEPTABLE. REVIEW OF THE EVENT AND OF RETURNED PRODUCT DOES NOT INDICATE THAT A MANUFACTURING DEFECT WAS PRESENT. QUALITY DATA REVIEWS OF THE OPTI20 AND OPTI FAMILY OF DEVICES DO NOT INDICATE A QUALITY THRESHOLD HAS BEEN EXCEEDED, THEREFORE, A CORRECTIVE ACTION WILL NOT BE INITIATED. THE ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA OPTI20 WAS USED FOR ECMO TREATMENT, MALE PATIENT WITH LOW CARDIAC OUTPUT, (B)(6). THE CANNULA WAS PLACED IN THE FEMORAL ARTERY, EVENING (B)(6) 2010. ON (B)(6) 2010 IN THE MIDDAY TIME THE NURSES NOTICED A LEAK OF THE CANNULA BETWEEN FLEXIBLE SHAFT AND CONNECTOR. THE ECMO SYSTEM STOPPED AND THE PATIENT LOST 3 LITERS OF BLOOD THROUGH THE HOLE OF THE DEFECT CANNULA. AFTERWARDS THE CANULAE WAS REPLACED WITH ANOTHER FEMORAL CANNULA. THE CANNULA WAS PLACED (B)(6) EVENING TIME AND THE PROBLEM OCCURED (B)(6) MIDDAY TIME. THIS IS MORE THAN 6 HOURS, AND PER DFU THIS PRODUCT IS INDICATED TO USE IT SHORT-TERM ( <6 HOURS). IT WAS ALSO REPORTED THAT THE KINK OF THE CANNULA OCCURRED FROM A CLAMP WHICH WAS PLACED AFTER THE NOTICE OF THE LEAK OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISITE ARTERIAL CANNULA ARTERIAL CANNULA DWF EDWARDS LIFESCIENCES OPTI20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR