BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 1911953 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05336
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE MICRO CATHETER WAS STUCK ON THE DISTAL PORTION OF THE GUIDE WIRE, LEAVING APPROXIMATELY 0.25" PROTRUDING FROM THE CATHETER TIP. THE WIRE WAS NOT ABLE TO BE REMOVED FROM THE CATHETER WITH SIGNIFICANT FORCE. IN AN ATTEMPT TO LOOSEN ANY DRIED BLOOD OR CONTRAST MEDIA THAT MIGHT BE PRESENT, THE DEVICE WAS PLACED IN A WARM, CIRCULATING BATH. HOWEVER, THIS HAD NO AFFECT ON LOOSENING THE WIRE. THE VERY DISTAL TIP OF THE CATHETER WAS CUT BACK AND IT WAS NOTED THAT A DISTINCT IMPRINT OF THE HTS (HIGH TORQUE SLEEVE) COULD BE SEEN THROUGH THE INNER LUMEN OF THE CATHETER TIP, INDICATING THAT AT SOME POINT THE MATERIAL HAD SWELLED INTO THE MIRCOCUTS OF THE WIRE. THE AVERAGE ID OF THE CATHETER AND THE AVERAGE OD OF THE GUIDE WIRE MEASURED RESULTING IN A GAP OF APPROXIMATELY 0.0017" IN BETWEEN THE TWO DEVICES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE BECAME STUCK ON A MICROCATHETER. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 185CM KINETIX GUIDE WIRE WAS INSERTED INTO A NON BSC MICROCATHETER WHICH WAS BEING UTILIZED FOR SUPPORT TO CROSS THE LESION. DURING ADVANCEMENT OF THE TWO DEVICES, THE PHYSICIAN TORQUED THE GUIDE WIRE AND UPON DOING SO, WAS UNABLE TO PUSH OR PULL THE GUIDE WIRE WITHIN THE MICROCATHETER. HE ATTEMPTED TO REMOVE THE MICROCATHETER, BUT WAS UNSUCCESSFUL; THEREFORE THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE BECAME STUCK ON A MICROCATHETER. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 185CM KINETIX GUIDE WIRE WAS INSERTED INTO A NON BSC MICROCATHETER WHICH WAS BEING UTILIZED FOR SUPPORT TO CROSS THE LESION. DURING ADVANCEMENT OF THE TWO DEVICES, THE PHYSICIAN TORQUED THE GUIDE WIRE AND UPON DOING SO, WAS UNABLE TO PUSH OR PULL THE GUIDE WIRE WITHIN THE MICROCATHETER. HE ATTEMPTED TO REMOVE THE MICROCATHETER, BUT WAS UNSUCCESSFUL; THEREFORE THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 13591532

    Patients

    Seq Age Sex Outcome Treatment
    1 ASAHI CORSAIR MICROCATHETER