BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/20 PRIORITY PACK W/CO-PILOT

    MDR report key: 2393247 · Received March 9, 2006

    Report

    Report Number
    2024168-2006-00191
    Event Type
    Malfunction
    Date Received
    March 9, 2006
    Date of Event
    February 2, 2006
    Report Date
    February 9, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO RECEIVED FROM UF REPORT: (B)(6). GUIDANT CORP. EQUIPMENTS USED ON CASE: CORDIS 6FV HEM SHEATH. GUIDANT 190CM PILOT 50 WIRE. CORDIS 6FR 3DRC. CYPHER 3 X 18 RX STENT. GUIDANT VOYAGER 3X 8MM RX BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE COPILOT DEVICE AND AS THE PHYSICIAN ATTEMPTED TO INJECT CONTRAST, AND AIR WAS INJECTED IN THE PT'S CORONARY ARTERY. NO PT INJURY WAS REPORTED. NO ADD'L INFO WAS AVAILABLE. ADD'L INFO RECEIVED FROM UF REPORT: LEFT HEART CATH (LHC) BEING PERFORMED; AT THE END OF CASE, WITH JUST THE CATHETER IN PLACE (WIRES HAD BEEN REMOVED), THE MD WENT TO INJECT CONTRAST, THE CO-PILOT DEVICE FAILED CAUSING AIR TO BE INTRODUCED INTO CATHETER AND INJECTED INTO RCA. EQUIP REMOVED, PT TOLERATED PROCEDURE WITHOUT ADVERSE EVENT. NOTE: MD DISCONNECTED CO-PILOT AND INJECTED MANUALLY WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20/20 PRIORITY PACK W/CO-PILOT GUIDANT ACCESSORY KIT DQX GUIDANT VASCULAR INTERVENTION NA 5121452

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR