BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEWIRE PRESSURE GUIDE WIRE

    MDR report key: 1699466 · Received May 25, 2010

    Report

    Report Number
    2939520-2010-00019
    Event Type
    Injury
    Date Received
    May 25, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE MANUFACTURING DOCUMENTATION FOR THE PRIMEWIRE (B) (4) AND THE S5 (B) (4) WERE REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED EVENT. TO DATE, THIS IS THE FIRST REPORTED ALLEGATION OF USER SHOCK RESULTING FROM VOLCANO DEVICE USAGE. THE PRIMEWIRE THAT WAS PRESENT IN THE PATIENT'S BODY AT THE TIME OF THE EVENT WAS DISPOSED OF BY HOSPITAL STAFF AND THUS NOT AVAILABLE FOR INVESTIGATION. THE S5 TOWER (B) (4) AND FFR PIMMETTE (B) (4) WERE HOWEVER, RETURNED TO VOLCANO FOR EVALUATION. WHEN THE PIMMETTE WAS RECEIVED, SAFETY AND FUNCTIONAL TESTING WERE PERFORMED AND NO PROBLEMS WERE FOUND. ALL DESIGNED SAFETY FEATURES FUNCTIONED AS INTENDED. THE DEVICE WAS THEN DISASSEMBLED AND INSPECTED AND NO PROBLEMS WERE FOUND. THE S5 SYSTEM ALSO UNDERWENT SAFETY AND FUNCTIONAL TESTING PER APPROVED PROCEDURES WITH NO PROBLEMS FOUND. ALL GROUND/EQUIPOTENTIAL CONNECTIONS WERE MADE AND WERE FIRMLY CONNECTED. THE CONSOLE AND MONITOR CABLING WAS VISUALLY INSPECTED WITH NO PROBLEMS FOUND. THE CPU INTERNAL WIRING WAS CHECKED FOR INTEGRITY AND ALL WIRING MET ASSEMBLY SPECIFICATIONS WITH NO DAMAGE TO THE WIRING INSULATION FOUND. ALL CONNECTIONS WERE MADE AND WERE FIRMLY CONNECTED. NO EVIDENCE WAS FOUND TO INDICATE ANY POTENTIAL FOR SHOCK HAZARD. THE CASE LOG IN THE CPU WAS REVIEWED AND ONE ADDITIONAL CASE WAS PERFORMED WITHOUT INCIDENT PRIOR TO REMOVAL OF THE SYSTEM FROM THE CATH LAB. THE HOSPITAL HAD A THIRD PARTY PERFORM A SAFETY CHECK TO VERIFY THE TOUCH VOLTAGE OF VARIOUS EQUIPMENT IN THE CATHETERIZATION LABORATORY. THE TABLE, STAND, AND OPERATING MODULES WERE APPROXIMATELY 3MV AND THE MONITOR SUSPENSION, SURGERY LIGHT, AND INJECTOR WERE APPROXIMATELY 7MV. THE SPECIFICATIONS REQUIRE THESE VALUES BE LESS THAN 100MV. NO FAILURE WAS FOUND. ALTHOUGH THE COMPLAINT IS FOR A PRIMEWIRE, THE PRIMEWIRE ITSELF DOES NOT GENERATE ELECTRICAL CURRENT. AT THE TIME OF THE EVENT, THE PRIMEWIRE WAS BEING USED WITH A VOLCANO S5 TOWER (B) (4) AND FFR PIMMETTE (P/N 807344-001, (B) (4)). THE FFR PIMMETTE CONTAINS A PATIENT ISOLATION BARRIER DESIGNED TO WITHSTAND 5KV ELECTRICAL POTENTIAL WITHOUT BREAKDOWN, AND TO LIMIT PATIENT LEAKAGE CURRENT TO 10UA. FOR THE PRIMEWIRE UNDER NORMAL OPERATION, THE VOLTAGE DIFFERENTIALS PRESENT IN THE WIRE ARE LESS THAN 1V, AND INSIDE THE PIMMETTE, THE POTENTIALS ON THE ISOLATED SIDE ARE ONLY 3.3V OR LESS. EVEN IN THE CASE OF FAILURE OF THE ISOLATION BARRIER, THE VOLTAGES PRESENT ON THE NON-ISOLATED (INSTRUMENT) SIDE OF THE BARRIER ARE SIGNIFICANTLY LESS THAN 50V, AND UNLIKELY TO PRODUCE A SENSATION OF ELECTRIC SHOCK FOR THE PHYSICIAN. ONLY IN THE CASE OF MULTIPLE FAILURES IN THE SYSTEM AND PIMMETTE COULD A HIGHER VOLTAGE (SUCH AS LINE VOLTAGE) APPEAR IN THE PIMMETTE, AND SUCH A FAILURE WOULD LIKELY DAMAGE THE ENTIRE SYSTEM (CAUSING THE COMPUTER AND DISPLAY TO FAIL). SINCE AT THE TIME OF THE SHOCK THE PHYSICIAN WAS WEARING GLOVES WHICH ACT AS AN ISOLATING BARRIER, AND THE GLOVES DID NOT APPEAR TO BE TORN OR OTHERWISE BREACHED, THE POTENTIAL MUST HAVE BEEN SIGNIFICANTLY HIGHER THAN 50V. TYPICAL BREAKDOWN STRENGTH OF A SURGICAL GLOVE (UNKNOWN COMPOSITION) IS AROUND 2500V. BASED ON THE SAFETY FEATURES DESIGNED INTO THIS SYSTEM AND THE RESULTS OF THE DEVICE/SYSTEMS EVALUATIONS, THIS FAILURE IS NOT LIKELY DUE TO A VOLCANO PRODUCT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION AT MID LAD JUST PAST THE FIRST DIAGONAL. THE LESION HAD BEEN PREVIOUSLY STUDIED WITH FFR SEVERAL MONTHS EARLIER AND PHYSICIAN WANTED TO USE FFR AGAIN. STAFF SET UP THE S5 TOWER AND SENT A PRIMEWIRE DOWN THE LAD WITH NO PROBLEMS. ONCE PAST THE LESION, PHYSICIAN ADMINISTERED THE IV ADENOSINE. THERE WERE NO ERRORS ON THE SCREEN AND NO PRESSURE PROBLEMS RECOGNIZED. THE PHYSICIAN WAS STANDING AT BEDSIDE FOR APPROXIMATELY 3 TO 4 MINUTES TO COMPLETE THE IV ADENOSINE. ONCE COMPLETED, HE REACHED DOWN TO TOUCH THE PRIMEWIRE JUST OUTSIDE THE TOUHY AND FELT A SHOCK LIKE A "SHARP STICK" TO HIS LEFT THUMB AND HIS HAND VISIBLY "JUMPED." THE S5 TOWER WAS TURNED OFF. PHYSICIAN THEN OBSERVED VESSELS BY ANGIO AND FOUND A DISSECTION PROXIMAL TO THE LESION. PHYSICIAN THEN REMOVED PRIMEWIRE AND USED GW TO FIX DISSECTION WITH A XIENCE 3.0X23MM DRUG ELUTING STENT. PATIENT IS REPORTED TO BE IN "GOOD" CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORPORATION 7903 120 02422

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention MEDTRONIC, 6F GUIDE| VOLCANO S5/FFR, (B) (4)