BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1901835 · Received November 17, 2010

    Report

    Report Number
    3008500478-2010-00015
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); HEMOSTASIS VALVE ON INTRODUCER.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT SHOULD HAVE BEEN SERIOUS INJURY DUE TO INITIAL REPORT OF BLOOD LOSS. EVALUATION: THE INTRODUCER USED WITH THE ENDOPLEGE CATHETER WAS RETURNED AND EVALUATED BY ENGINEERING IN EDWARDS (B)(4). THE INTRODUCER IS MANUFACTURED IN EDWARDS (B)(4) AND SENT TO (B)(6) TO BE KITTED WITH THE EP. ACCELLENT VERIFIED THAT INTRODUCER LOT NUMBER 58894040 WAS USED WITH THE EP LOT. A DHR REVIEW PERFORMED INDICATED THAT THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THE LOT. THE EP LOT NUMBER WAS UNKNOWN THEREFORE A DHR REVIEW COULD NOT BE PERFORMED FOR THIS THE EP DEVICE. VISUAL INSPECTION OF THE INTRODUCER SHOWED A VISIBLE KINK IN THE SHAFT, ABOUT 1 CM FROM THE SHEATH HUB. THE CAP OF THE INTRODUCER WAS REMOVED TO EXAMINE THE STAINLESS STEEL RINGS AND THE SILICONE VALVE. THE STAINLESS WERE IN THE CORRECT ORIENTATION AND THERE WAS NO SIGN OF DAMAGE OBSERVED ON IT UNDER 30X - 45X MAGNIFICATION. HOWEVER, THE VALVE WAS NOT PRESENT BETWEEN THE TWO STAINLESS RINGS OR ANYWHERE IN THE INTRODUCER. ALL THE INTRODUCERS ARE 100% LEAK TESTED ON THE MANUFACTURING FLOOR. DURING ONE OF THE LEAK TESTS, THE DILATOR IS PLACED IN THE INTRODUCER. IT WAS CONFIRMED THAT IF THE VALVE WAS NOT PRESENT THE PART WOULD FAIL LEAK. A PRODUCT RISK ASSESSMENT AND CORRECTIVE ACTION (#CAPA CSS-GEN-(B)(4)) WERE INITIATED TO DETERMINE AND ADDRESS THE ROOT CAUSE OF VALVE DISLODGEMENT. A FIELD CORRECTION ACTION WAS INITIATED ON (B)(4), 2010 AS A RESULT OF THE PRODUCT RISK ASSESSMENT. EACH CUSTOMER EXPERIENCE REPORT IS THOROUGHLY REVIEWED TO ENSURE APPROPRIATE RISK CONTROL MEASURES ARE IN-PLACE. CAPA # (B)(4) HAS BEEN INITIATED TO DETERMINE AND ADDRESS THE ROOT CAUSE OF VALVE DISLODGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A PROBLEM WITH 11FR INTRODUCER THAT ACCOMPANIES THE ENDOPLEGE CATHETER. THERE WAS SIGNIFICANT BLOOD LEAKING OUT OF THE HAEMOSTATIC VALVE OF THE 11FR EP INTRODUCER ALMOST IMMEDIATELY AFTER THE INTRODUCER WAS ADVANCED INTO THE PATIENTS INTERNAL JUGULAR VEIN. THIS PROBLEM OCCURRED BEFORE CUSTOMER ATTEMPTED TO PASS THE EP CATHETER THROUGH THE INTRODUCER. THIS PROBLEM DID NOT CAUSE ANY PATIENT HARM. THEY SIMPLY REMOVED THE DEFECTIVE EP INTRODUCER AND OPENED UP A NEW ONE WHICH WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other