BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 6294485 · Received February 1, 2017

    Report

    Report Number
    2939520-2017-00011
    Event Type
    Death
    Date Received
    February 1, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 5, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225001100
    PMA / PMN Number
    K111395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT AFTER IVUS WAS COMPLETED THE IVUS CATHETER WAS REMOVED. THE IVUS CATHETER DEVICE REFERENCED WAS MANUFACTURED BY THIS COMPANY. THE PHYSICIAN DID NOT BELIEVE EITHER THE MANUFACTURER'S IVUS CATHETER OR FFR WIRE CONTRIBUTED TO THE ADVERSE EVENT. A MEDWATCH REPORT WAS SUBMITTED ON 02-03-2017 UNDER MDR 2939520-2017-00014 FOR THE IVUS CATHETER. THIS FOLLOW-UP REPORT IS TO CLARIFY THE TWO MDRS ARE TIED TO THE SAME PROCEDURE AND NOTE THAT AN MDR WAS SUBMITTED FOR EACH DEVICE AND NOTE THE MDR FOR THIS SUBMISSION, 2939520-2017-00011, WAS ALSO IDENTIFIED WITHIN MDR 2939520-2017-00014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED THAT AFTER IVUS WAS COMPLETED AND REMOVED, WE [THE PHYSICIAN] INSERTED THE [MANUFACTURERS DEVICE]. HAD DIFFICULTY AT THE LEFT MAIN, AND THEN NOTICED NO FLOW. REMOVED WIRE AND BEGAN CPR, PATIENT EXPIRED 30 MINUTES LATER ON THE PROCEDURE TABLE. 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 DEVICE WITHIN THE GUIDE CATHETER TO MEASURE FFR, PRIOR TO NORMALIZATION, THE PATIENT BEGAN TO CODE. ALL DEVICES WERE REMOVED FROM THE PATIENT AND CPR WAS INITIATED. THIRTY (30) MINUTES LATER THE PATIENT EXPIRED ON THE TABLE. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS MET AND DEVICE WAS NOT STUCK. 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). THE INSTRUCTIONS FOR USE (IFU) WARNS, ADVERSE EFFECTS: AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY BE ENCOUNTERED WITH THE USE OF THE [MANUFACTURERS] GUIDE WIRE. THE MAJOR RISKS OF CORONARY ANGIOGRAPHY AND CORONARY ANGIOPLASTY INCLUDE: CORONARY VESSEL DISSECTION, OCCLUSION, PERFORATION, EMBOLUS, SPASM, LOCAL AND/OR SYSTEMIC INFECTION, PNEUMOTHORAX, MYOCARDIAL INFARCTION, SERIOUS ARRHYTHMIAS AND DEATH. THE MAJOR RISKS OF PERIPHERAL ANGIOGRAPHY OR PERIPHERAL ANGIOPLASTY INCLUDE: DISSECTION, ABRUPT CLOSURE, PERFORATION, EMBOLUS, AND SPASM. ADDITIONALLY, THE INSTRUCTIONS FOR USE (IFU) WARNS, PRECAUTIONS: THE FUNCTIONAL MEASUREMENT (PRESSURE OR FLOW) WIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS ENCOUNTERED. THE WIRE SHOULD NEVER BE FORCIBLY PUSHED INTO A VESSEL. ANYTIME THAT RESISTANCE IS ENCOUNTERED, THE WIRE SHOULD BE WITHDRAWN UNDER FLUOROSCOPIC GUIDANCE. 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
    76468 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 9185 0110 50081322 00845225001100

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death