BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 MODERATE SUPPORT GUIDEWIRE

    MDR report key: 727913 · Received June 19, 2006

    Report

    Report Number
    6000130-2006-00144
    Event Type
    Injury
    Date Received
    June 19, 2006
    Date of Event
    June 9, 2006
    Report Date
    June 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC SCIMED, INC.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    DURING A PCI PROCEDURE, THE PT2 MODERATE SUPPORT GUIDEWIRE SEPARATED AND WAS LEFT IN THE PATIENT. THE LESION BEING TREATED WAS A 100% STENOTIC LESION IN THE RIGHT CORONARY ARTERY. (RCA). A RINATO GUIDEWIRE WAS INSERTED INTO A LAUNCHER 6F JL4 GUIDE CATHETER AND ATTEMPTED TO CROSS THE LESION, BUT IT WAS DIFFICULT TO PASS THE LESION. THE PHYSICIAN INSERTED A PT2 GUIDEWIRE AND SUCCESSFULLY CROSSED THE LESION. THE RINATO GUIDEWIRE WAS WITHDRAWN FROM THE CORONARY ARTERY AND A 1.5MM X 20MM MAVERICK2 MONORAIL PTCA CATHETER WAS INSERTED TO THE LESION ALONG WITH A PT2 GUIDEWIRE. THE MAVERICK2 MONORAIL PTCA CATHETER CROSSED THE LESION SMOOTHLY , AND THE BALLOON WAS INFLATED AT 6 ATMS FOR 30 SECONDS. THE LESION WAS DILATATED AND THE DISTAL BRANCHES WERE CONFIRMED BY ANGIOGRAPHY. IT WAS NOTED THAT A LATERAL BRANCH WAS GROWN DOWN FROM RCA 4AV TO THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE LCX SEG13 WAS 99% STENOTIC AND VERY THIN. THE GUIDEWIRE WAS PLACED AT THE MIDDLE OF THE RCA SEG3. THE TIP OF THE EXCELSIOR MICRO CATHETER WAS INSERTED TO THE 4AV DISTAL END AND WAS EASILY ADVANCED TO THE SEG13 RCA SEG2 WAS NOT DILATED ENOUGH RESTITUTED, THEREFORE, A PIXCEL 2.5X13MM WAS PLACED AT THE PROXIMAL SEG2 AND DILATATED AT 8 ATMS FOR 30 SECONDS. ELASTIC RECOIL OCCURRED 5 MINUTES LATER AND THE PIXCEL 2.5X13MM WAS PLACED AND INFLATED AT 12 ATMS FOR 30 SECONDS. THE LESION WAS SUCCESSFULLY DILATATED. THE PT2 MODERATE SUPPORT GUIDEWIRE WAS ADVANCED FROM LCX SEG 13 TO SEG 14. THE TIP OF THE DEVICE WAS CURVED GENTLY, BUT DID STRAIGHTEN AND SEPARATION WAS NOT NOTED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE PT2 MODERATE SUPPORT GUIDEWIRE. THE GUIDEWIRE WAS WITHDRAWN WITHOUT RESISTANCE, BUT THE TIP SEPARATION WAS NOTICED DURING WITHDRAWAL. IT WAS DIFFICULT TO RETRIEVE THE SEPARATION. THE SEPARATION WAS LEFT AT SEG 14. NO ADVERSE EFFECTS ON BLOOD FLOW. THE PROCEDURE WAS THEN TERMINTATED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 MODERATE SUPPORT GUIDEWIRE PTCA GUIDEWIRE LOX BOSTON SCIENTIFIC SCIMED, INC. 185CM STR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other