BEUDAMED
    FDA Adverse Event Death Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 6302681 · Received February 3, 2017

    Report

    Report Number
    2939520-2017-00014
    Event Type
    Death
    Date Received
    February 3, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 5, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K143701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PLEASE NOTE: THIS MDR IS RELATED TO MDR 2939520-2017-00011 INVOLVING ONE (1) PATIENT. THE EVENTS DESCRIBED BELOW OCCURRED DURING THE SAME PROCEDURE. THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED THAT AFTER IVUS WAS COMPLETED, THE MANUFACTURERS IVUS CATHETER WAS REMOVED. UPON INSERTING THE MANUFACTURERS FFR WIRE IT WAS REPORTED THE PHYSICIAN HAD DIFFICULTY AT THE LEFT MAIN, AND THEN NOTICED NO FLOW. THE PHYSICIAN REMOVED ALL DEVICES FROM THE PATIENT AND BEGAN CPR. PATIENT WAS PRONOUNCED DECEASED 30 MINUTES LATER. PATIENT CONDITION: DEATH VESSEL DETAILS: MID/DISTAL LAD, 4.2MM TWO (2) AREA PLAQUE BURDEN. IT WAS FURTHER REPORTED THE PATIENT HAD BEEN DIAGNOSED WITH CANCER AND WAS SCHEDULED TO BE SENT FOR TREATMENT. PRE-CANCER TREATMENT LABS REVEALED ELEVATED LEVELS OF TROPONIN. THE PATIENT WAS SENT FOR AN ANGIOGRAM. DURING THE ANGIOGRAM THE PHYSICIAN INSERTED AND REMOVED IVUS CATHETER TO SUCCESSFULLY MEASURE THE PLAQUE BURDEN. WHEN ADVANCING THE MANUFACTURERS WIRE WITHIN THE GUIDE CATHETER TO MEASURE FFR, PRIOR TO NORMALIZATION, THE PATIENT BEGAN TO CODE. THE PHYSICIAN STATED THAT HE BELIEVES NEITHER THE MANUFACTURERS IVUS CATHETER OR FFR WIRE CONTRIBUTED TO THE EVENT. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS MET AND DEVICE WAS NOT STUCK. THE IVUS PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. OTHER DEVICES IN USE: BOSTON SCIENTIFIC GUIDE CATHETER LBU3.75, TERUMO RUN THROUGH WIRE, INTRODUCER NEEDLE (MANUFACTURER NOT PROVIDED), VOLCANO FFR WIRE. THE INSTRUCTIONS FOR USE (IFU) WARNS, ADVERSE EFFECTS: POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: MYOCARDIAL INFARCTION; OCCLUSION; CORONARY VESSEL DISSECTION; PERFORATION, RUPTURE OR INJURY; RESTENOSIS; HEMORRHAGE OR HEMATOMA; UNSTABLE ANGINA; ARRHYTHMIAS; DRUG REACTIONS; ALLERGIC REACTION TO CONTRAST MEDIUM; HYPO/HYPERTENSION; INFECTION; VESSEL SPASM; ARTERIOVENOUS FISTULA; EMBOLISM; ENTRY PUNCTURE SITE BLEEDING; VASCULAR WALL INJURY; VESSEL THROMBOSIS; PSEUDOANEURYSM (AT SITE OF CATHETER INSERTION); RENAL FAILURE; CORONARY ANEURYSM; VESSEL TRAUMA REQUIRING SURGICAL REPAIR OR INTERVENTION, DEATH. THIS MDR IS BEING SUBMITTED DUE TO THE DEATH OF THE PATIENT. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82941 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 9185

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death