BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAGLE EYE PLATINUM SHORT TIP

    MDR report key: 5767035 · Received July 1, 2016

    Report

    Report Number
    2939520-2016-00042
    Event Type
    Injury
    Date Received
    July 1, 2016
    Report Date
    April 26, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO PHILIPS VOLCANO POLICY. ATTEMPTS TO OBTAIN PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION WERE MADE VIA EMAIL AND PHONE. ALL REASONABLY KNOWN PATIENT INFORMATION IS INCLUDED IN THIS REPORT. EVENT DATE: ATTEMPTS TO GAIN DATE OF PROCEDURE HAVE BEEN UNSUCCESSFUL. ADDITIONAL INFORMATION OBTAINED INDICATED THROMBUS WAS NOTED AFTER THE IVUS CATHETER WAS REMOVED FROM THE VESSEL. OTHER DEVICES WERE A JL4 GUIDE WITH A KINETIX WIRE. THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX WHEN THROMBUS WAS NOTICED. CUSTOMER INDICATED IT IS NORMAL PRACTICE TO CHECK ACT DURING INTERVENTIONAL PROCEDURES AFTER HEPARIN OR ANGIOMAX IS GIVEN. AN ASPIRATION CATHETER WAS USED TO REMOVE THE CLOT. NO TESTS/LABORATORY DATA WAS AVAILABLE. NO INFORMATION WAS AVAILABLE. SERIAL #, LOT# AND EXPIRATION DATE: THE CUSTOMER WAS UNABLE TO PROVIDE LOT NUMBER OR SERIAL NUMBER; THEREFORE, DOCUMENTATION RELATED TO THE DEVICE (COMPLAINT DATABASE/SFDC, NCR DATABASE, ETC.) CANNOT BE REVIEWED. (B)(4) LOTS WERE RELEASED TO THE CUSTOMER BETWEEN 11/02/2015 THROUGH 04/25/2016. THE MANUFACTURING DOCUMENTATION FOR THESE (B)(4) LOTS WAS REVIEWED. ALL RELEASED UNITS WERE MANUFACTURED IN (B)(4) AND WERE MANUFACTURED TO SPECIFICATION. THERE ARE NO NCRS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE. TO DATE, ONE OTHER COMPLAINT WAS REPORTED FOR THIS SAME FAILURE MODE WITHIN THESE LOTS. WE WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. HEALTH PROFESSION WAS AN INTERVENTIONAL CARDIOLOGIST. ATTEMPTS TO GAIN NAME HAVE BEEN UNSUCCESSFUL. OCCUPATION OF REPORTING INDIVIDUAL IS CATH LAB MANAGER. PMA 510(K): THE 510K CODING FOR THE POTENTIAL (B)(4) LOTS FALL UNDER EITHER K120697 OR K143701. NO PHYSICAL PRODUCT INVESTIGATION WAS POSSIBLE AS THE DEVICE WAS DISCARDED AT THE FACILITY AND NOT RETURNED FOR ANALYSIS. EXPIRATION DATE IS UNKNOWN AS THE CUSTOMER WAS UNABLE TO PROVIDE LOT OR SERIAL NUMBER OF THE DEVICE. B ADDITIONAL INFORMATION OBTAINED INDICATED ONE PASS WAS MADE WITH THE CATHETER AND NO RESISTANCE WAS EXPERIENCED. PER THE MANUFACTURER'S MEDICAL AUTHORITY, IT IS POSSIBLE THE MANUFACTURER'S DEVICE COULD HAVE CAUSED A THROMBUS FORMATION IF THERE WERE DEVICE-RELATED FACTORS SUCH AS SURFACE IRREGULARITY, EXCESSIVE INDWELL TIME, AND/OR COATING DEFECTS. AS WE DID NOT GET THE DEVICE BACK FOR ANALYSIS AND ADDITIONAL ATTEMPTS FOR PROCEDURAL INFORMATION WAS UNSUCCESSFUL, WE ARE REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. THE MEDICAL AUTHORITY ALSO NOTED IT WAS POSSIBLE SITE-RELATED FACTORS WERE CONTRIBUTORY. THE PRESCRIBING INFORMATION FOR ANGIOMAX®, A THROMBIN INHIBITOR INDICATED FOR USE AS AN ANTICOAGULANT IN PATIENTS, UNDER §6.3 POSTMARKETING EXPERIENCE LISTS THROMBUS FORMATION DURING PCI WITH AND WITHOUT INTRACORONARY BRACHYTHERAPY AS ONE OF THE ADVERSE REACTIONS DURING POSTAPPROVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNUSUAL CLOT FORMATION WAS OBSERVED IN THE VESSEL DURING PULL BACK. THE CASE WAS ABLE TO BE COMPLETED WITHOUT EXCHANGING THE IVUS FOR ANOTHER AND NO ADDITIONAL INTERVENTION WAS REQUIRED. DEVICE WAS DISPOSED OF AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY. PATIENT HAD NO PRE-EXISTING CLOTTING CONDITIONS. VESSEL: MID TO DISTAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419781 EAGLE EYE PLATINUM SHORT TIP CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 85900PST

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention