BEUDAMED
    FDA Adverse Event Death Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 6546455 · Received May 4, 2017

    Report

    Report Number
    2939520-2017-00047
    Event Type
    Death
    Date Received
    May 4, 2017
    Date of Event
    March 31, 2017
    Report Date
    May 3, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    UDI-DI
    00845225001278
    PMA / PMN Number
    K143701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. BASED ON THE PREVIOUS ASSESSMENT OF THIS PA-PD SHIFT COMPLAINT, THE INITIAL INFORMATION AVAILABLE SUGGESTED THAT IF PA-PD WAVEFORM SHIFT OCCURS, INACCURATE MEASUREMENTS COULD CONTRIBUTE TO INCORRECT TREATMENT DECISIONS. THE MANUFACTURER'S OPERATOR'S MANUAL REQUIRES USE ONLY BY TRAINED MEDICAL PERSONNEL AND CAUTIONS THAT "FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN (OR PROPERLY LICENSED PRACTITIONER)." ADDITIONALLY, THE OPERATOR'S MANUAL STATES THAT THE FFR OPTION ON THE MANUFACTURER'S SYSTEM SHOULD BE USED ONLY BY PHYSICIANS WHO ARE THOROUGHLY TRAINED IN CARDIAC OR PERIPHERAL VESSEL CATHETERIZATION PROCEDURES. THE FRACTIONAL FLOW RESERVE (FFR) OPTION ON THE MANUFACTURER'S SYSTEM REQUIRES TWO PRESSURE SIGNALS (PD AND PA) TO EXECUTE NORMALIZATION AND CALCULATE RESULTS. THE MANUFACTURER'S PRESSURE WIRE, PROVIDES THE DISTAL PRESSURE SIGNAL (PD). THE PHYSIOLOGIC AORTIC PRESSURE SIGNAL (PA) COMES FROM A SENSOR THAT IS PART OF THE HEMODYNAMIC MONITORING SYSTEM, A NON-MANUFACTURER'S PRODUCT. THE AORTIC PRESSURE SENSOR AND ATTACHED GUIDE CATHETER ARE SET-UP AND POSITIONED BY THE PHYSICIAN SEPARATE FROM MANUFACTURER'S PRESSURE WIRE. NORMALIZATION IS PERFORMED WITH THE WIRE'S PRESSURE SENSOR LOCATED AT THE TIP OF THE GUIDE CATHETER WITHIN THE CORONARY ARTERY. THEREFORE, THE PHYSICIAN INITIATES NORMALIZATION ONCE THEY HAVE CONFIRMED THE PLACEMENT OF THE PRESSURE WIRE. BASED ON THE ABOVE DESCRIBED FACTORS (PD COMING FROM VOLCANO'S PRESSURE WIRE, PA COMING FROM A NON-MANUFACTURER'S PRODUCT, AND PHYSICIAN'S INITIATION OF NORMALIZATION UPON CONFIRMATION OF PLACEMENT OF PRESSURE WIRE), THE PHYSIOLOGIC AORTIC PRESSURE SIGNAL CAN CONTAIN CONTENT THAT MAY CAUSE A ONE CARDIAC CYCLE SHIFT. REFER TO MANUFACTURER'S OPERATOR'S MANUAL, SECTION ACQUIRE FFR PRESSURE MEASUREMENTS FOR WARNING ON DISCONTINUING USE OF THE SYSTEM, AND CONTACTING MANUFACTURER'S TECHNICAL SUPPORT IF NORMALIZATION FAILS TO ESTABLISH A PD/PA RATIO OF 1.0 AFTER MULTIPLE ATTEMPTS. MANUFACTURER'S PRODUCT MANAGES SUCH A SHIFT BY DISPLAYING THE NORMALIZED WAVEFORMS SO THAT THE USER CAN DETECT A ONE-CARDIAC CYCLE SHIFT. MANUFACTURER'S SOFTWARE (FFR V2.4 SOFTWARE) ALLOWS THE USER TO EVALUATE THE RESULTS OF THE NORMALIZATION PROCESS AND MAKE ADJUSTMENTS IF NEEDED. THE ONE-CARDIAC CYCLE SHIFT IS NOT CAUSED BY MANUFACTURER'S SOFTWARE AND THIS NOT A PRODUCT PERFORMANCE ISSUE, AS THE PRODUCT IS WORKING AS DESIGNED THE APPROPRIATE ACTION IS TO REVIEW THE PRESENTED WAVEFORMS AND RE-NORMALIZE WITH THE GOAL OF ACHIEVING A SHIFT FREE NORMALIZATION. MANUFACTURER'S FFR V2.4 OPERATOR'S MANUAL HAS INSTRUCTIONS IN THAT IF THE USER IS UNABLE TO ESTABLISH A POST-NORMALIZATION PD/PA RATIO OF 1.0 WITH OVERLAPPING WAVEFORMS AFTER SEVERAL ATTEMPTS, THEY ARE INSTRUCTED TO CONTACT MANUFACTURER'S TECHNICAL SUPPORT. AS DESCRIBED IN THIS DOCUMENT, FFR VERSION V2.4 IS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. NO TESTS/LABORATORY DATA WAS AVAILABLE. NO INFORMATION WAS AVAILABLE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. NO PHYSICAL PRODUCT INVESTIGATION WAS POSSIBLE AS THE DEVICE WAS DISCARDED AT THE FACILITY. 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.

    Description of Event or Problem · 1

    THIS EVENT IS BEING SUBMITTED TO CORRECT AND CLARIFY INFORMATION PROVIDED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CORONARY PROCEDURE, THE PATIENT SUFFERED A MAJOR ADVERSE CARDIAC EVENT (MACE) AND EXPIRED TWO DAYS LATER IN THE ICU. THE CATHETER IS REPORTED TO NOT HAVE BEEN IN THE PATIENT AT THE TIME THE PATIENT SUFFERED THE MACE. PER THE PHYSICIAN, THE CATHETER DID NOT CAUSE ANY PATIENT INJURY. THE PATIENT WENT TO SURGERY BY HIS CLINICAL CONDITION. THE CATHETER WAS INSPECTED DURING PREP AND WAS IN GOOD CONDITION. NO RESISTANCE WAS FELT AT ANY TIME. DEVICE WAS IN GOOD CONDITION WHEN REMOVED FROM THE PATIENT. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. PATIENT'S TREATMENT WAS COMPLETED BY THE PROCEDURE. VESSEL: LAD. ADDITIONAL DEVICES IDENTIFIED AS BEING USED DURING THE PROCEDURE BUT NOT MANUFACTURED BY THIS MANUFACTURER WERE A GUIDE CATHETER (BL 3.5F) AND GUIDE WIRE (WHISPER). THIS EVENT IS BEING REPORTED BECAUSE THE PATIENT EXPIRED. THIS SUBMISSION IS FOR THE CATHETER USED DURING THE PROCEDURE. AN MDR FOR THE SYSTEM USED DURING THE PROCEDURE WAS SUBMITTED UNDER MDR 2939520-2017-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327415 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 85900P 0127 50083421 00845225001278

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death