BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1003413 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00501
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROTALINK PLUS WAS REC'D WITH BLOOD IN THE CATHETER SHEATH AND A GUIDE WIRE INSIDE THE UNIT. THE CATHETER SHEATH HAD BEEN SEPARATED IN TWO SECTIONS. ONE SECTION OF THE CATHETER SHEATH WAS 23.4CM IN LENGTH FROM THE TIP OF THE STRAIN RELIEF. THE OTHER SECTION OF THE CATHETER SHEATH WAS 110CM IN LENGTH. THE AREAS WHERE THE CATHETER SHEATH WAS DAMAGED WERE MICROSCOPICALLY EXAMINED. THE AREA WHERE THE FRACTURE OCCURRED WAS JAGGED IN APPEARANCE. THE AREAS AT EITHER SIDE OF WHERE THE FRACTURE OCCURRED WERE DEFORMED AND APPEARED STRETCHED OR CRUSHED. THE AREA WHERE THE TRI-FILAR COIL WAS EXPOSED AS A RESULT OF BROKEN CATHETER SHEATH WAS COVERED IN CLEAR FIBERS. THE FIBERS THAT WERE NOTED ON THE EXPOSED SECTION OF THE COIL AS A RESULT OF BEING BROKEN CATHETER SHEATH DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE CATHETER WAS SOAKED IN WARM WATER FOR FIVE MINS TO AID IN THE REMOVAL OF THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED FROM THE CATHETER. NO KINKS WERE NOTED IN THE GUIDE WIRE. IT WAS NOTED THAT THE DFU FOR THE ROTABLATOR WAS NOT FOLLOWED. THE ROTABLATOR DFU STATES THAT "IF THE HEMOSTASIS VALVE IS TIGHTENED EXCESSIVELY, IT CAN CRUSH THE SHEATH AROUND THE DRIVE SHAFT AND CAUSE PERMANENT DAMAGE TO THE ROTALINK CATHETER. THE HEMOSTASIS VALVE SHOULD BE CLOSED JUST TIGHT ENOUGH TO PREVENT BLOOD LOSS, BUT STILL ALLOW THE ROTALINK SHEATH TO SLIDE THROUGH THE VALVE." THE MOST PROBABLE ROOT CAUSE OF THE SHEATH FRACTURE CAN BE ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED 01/24/2008: IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A SHAFT KINK OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, HOWEVER, THE PERCENT OF THE STENOSIS OF THE LESION, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNK. THE ROTABLATOR ROTALINK PLUS 1.50MM ATHERECTOMY DEVICE MADE ONE SUCCESSFUL RUN. THE PHYSICIAN WITHDREW THE DEVICE AND PRIOR TO ATTEMPTING A SECOND RUN NOTED THAT THE MID-CATHETER CONTAINED A KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "FINE". DEVICE ANALYSIS REVEALED A SHEATH FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 11213578

    Patients

    Seq Age Sex Outcome Treatment
    1