BEUDAMED
    FDA Adverse Event Death Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 6683255 · Received June 30, 2017

    Report

    Report Number
    2939520-2017-00060
    Event Type
    Death
    Date Received
    June 30, 2017
    Date of Event
    November 23, 2016
    Report Date
    May 31, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K143701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ATTEMPTS TO OBTAIN PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION WERE MADE VIA EMAIL AND PHONE. ATTEMPTS TO DATE TO OBTAIN DATE OF DEATH WERE UNSUCCESSFUL. THE HOSPITAL DID NOT INFORM THE MANUFACTURER OF THIS EVENT. THE MANUFACTURER'S SALES MANAGER FOR THE HOSPITAL WAS APPRISED OF THE EVENT ON (B)(6) 2017, WHO CONTACTED THE HOSPITAL SAME DAY. THE NURSE AT THE HOSPITAL EXPLAINED THE INCIDENT OCCURRED DURING AN IVUS PROCEDURE AND THAT THE MONITOR SHUT DOWN (NO IMAGE) AND THEREFORE, THERE WAS A PROLONGATION OF THE CASE. THE NURSE SAID IT WAS A COMPLEX SITUATION DUE TO THE PATIENT'S CONDITION AND THE PATIENT'S DEATH WAS PROBABLY NOT CAUSED BY OUR DEVICES. THE NURSE HAD NO MORE INFORMATION BUT INDICATED SHE WOULD TRY TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING THE PROCEDURE. AS OF THE DATE OF THIS REPORT SUBMISSION, NO FURTHER INFORMATION REGARDING THE PROCEDURE IS KNOWN BY THE MANUFACTURER. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE BASED ON CURRENT INFORMATION. DEVICE NOT RETURNED TO THE MANUFACTURER. (B)(6). NO PHYSICAL PRODUCT INVESTIGATION; CATHETER DEVICE WAS NOT RETURNED TO THE MANUFACTURER. DATE DEVICE MANUFACTURED IS UNKNOWN AS CATHETER DEVICE SERIAL AND/OR LOT NUMBER WAS NOT IDENTIFIED BY THE HOSPITAL, AND WAS NOT RETURNED TO THE MANUFACTURER. A REVIEW OF THE HOSPITAL'S PURCHASE HISTORY INDICATES THE CUSTOMER HAS NOT ORDERED ANY OTHER TYPE OF CATHETER DEVICE FROM THE MANUFACTURER THAN REPORTED IN THIS REPORT. IN THE SIX MONTHS PRIOR (5/3/2016 - 11/08/2016) TO THE EVENT ((B)(6) 2016). DHRS FOR THE LOTS SHIPPED TO THE CUSTOMER DURING THE 6-MONTHS PERIOD PRIOR TO THE PROCEDURE WERE REVIEWED AND THE CATHETER DEVICES RELEASED FOR SAME MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THE SYSTEM USED DURING THE PROCEDURE WAS ALSO A DEVICE FROM THE MANUFACTURER AND IS BEING INVESTIGATED AND SEPARATELY SUBMITTED UNDER MDR 2939520-2017-00061. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE MANUFACTURER RECEIVED AN E-MAIL FROM (B)(6) HEALTH CARE INSPECTORATE INFORMING US THE MANUFACTURER'S CUSTOMER REPORTED TO THE INSPECTORATE THAT A PATIENT HAD DIED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. IT WAS ALSO REPORTED WITHIN THE EMAIL THAT ONE OF THE CAUSES COULD BE A DELAY OF THE PROCEDURE; THE DELAY COULD HAVE BEEN CAUSED BY A MALFUNCTION OF THE SYSTEM. THIS EVENT IS BEING REPORTED AS AN ADVERSE EVENT OF PATIENT DEATH OCCURRED IN WHICH A CATHETER DEVICE FROM THE MANUFACTURER MAY HAVE BEEN USED DURING THE REFERENCED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463336 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 85900P

    Patients

    Seq Age Sex Outcome Treatment
    1 Death