BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR 1018 MICROCATHETER

    MDR report key: 761466 · Received August 2, 2006

    Report

    Report Number
    6000078-2006-00357
    Event Type
    Malfunction
    Date Received
    August 2, 2006
    Date of Event
    July 7, 2006
    Report Date
    July 7, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR
    Product Code
    FOZ
    PMA / PMN Number
    k013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOCK G5: PMA/510(K) #: K042568/ K994155. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC BECAUSE IT WAS DISPOSED OF BY THE HOSP. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY IN REMOVING THE PT2 MODERATE SUPPORT GUIDEWIRE AND THE TIP OF THE DEVICE CHANGED SHAPE, WHEN IT CAUGHT ON ANOTHER DEVICE. THE LESION BEING TREATED WAS A 99% STENOTIC LESION IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A 6F EVU3.5 GUIDE CATHETER AND A RUNTHROUGH GUIDEWIRE CROSSED THE LESION IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY AND THE PT2 MODERATE SUPPORT GUIDEWIRE CROSSED THE OBTUSE MARGINAL BRANCH (OM). THE LESION WAS DILATED WITH A 3.0MM AVITA BALLOON DILATATION CATHETER AND IVUS IMAGING WAS PERFORMED. A CYPHER 23MM X 3.0MM STENT WAS DEPLOYED AND IVUS IMAGING WAS PERFORMED AGAIN. IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS FLOATING. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE ATLANTIS SR CORONARY IMAGING CATHETER BUT WAS UNSUCCESSFUL. HE ATTEMPTED TO WITHDRAW THE PT2 MODERATE SUPPORT GUIDEWIRE WITH THE EXCELSIOR, BUT HE WAS UNABLE TO WITHDRAW EITHER DEVICE. THEREFORE, HE WITHDREW THE ENTIRE DELIVERY SYSTEM TOGETHER. THE PT2 MODERATE SUPPORT GUIDEWIRE BECAME CAUGHT IN THE EXIT PORT OF AN ATLANTIS SR CORONARY IMAGING CAHTETER. THE TIP OF THE PT2 MODERATE SUPPORT GUIDEWIRE CHANGED SHAPE (RESEMBLED A PIG TAIL) AND THE EXIT PORT OF THE ATLANTIS WAS STRETCHED. THE EXCELSIOR KINKED DURING WITHDRAWAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR 1018 MICROCATHETER INFUSION CATHETER FOZ BOSTON SCIENTIFIC CORP, NEUROVASCULAR 144381 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * (MFR REPORT 6000084-2006-00037)| 3.0 AVITA, CYPHER 23/3.0 (UNK)| GC 6F EVU3.5, GW RUNTHROUGH| F/G ATLANTIS SR PRO2| (MFR REPORT 6000130-2006-00187)| PT2 MODERATE SUPPORT GUIDEWIRE