BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1022184 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00914
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROTALINK PLUS UNIT WAS RETURNED LOADED WITH A GUIDE WIRE. IT WAS NOTED THAT THE GUIDE WIRE SPRING TIP WAS STRETCHED. THE GUIDEWIRE WAS REMOVED FROM THE ROTALINK PLUS UNIT WITH EASE. THE ROTALINK PLUS CATHETER AND ADVANCER HANDSHAKE CONNECTIONS WERE CONNECTED WHEN RETURNED TO THE COMPLAINTS LAB. THE HANDSHAKE CONNECTIONS WERE DISCONNECTED AND RECONNECTED AND A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED WITH THE UNIT'S HANDSHAKE CONNECTIONS. THE BURR WAS MICROSCOPICALLY EXAMINED AND IT WAS NOTED THAT THE ANNULUS OF THE BURR WAS DAMAGED WITH SHARP EDGES. A TEST ROTAWIRE FLOPPY GUIDE WIRE 325CM, WAS LOADED INTO THE ROTALINK PLUS UNIT WITH NO ISSUES NOTED DURING LOADING OF THE GUIDE WIRE. THE ROTALINK PLUS UNIT WAS WET TESTED ALONG WITH THE TEST ROTAWIRE. THE BURR MAINTAINED A SPEED OF 175,000RPM FOR ONE MINUTE AT A PRESSURE OF 56PSI. A PRESSURE OF <58PSI IS ACCEPTABLE. THE BURR WAS ADVANCED AND RETRACTED THROUGHOUT THE WET TEST. THE BURR WAS STALLED AT 150,000RPM; THE BURR RECOVERED BACK TO A SPEED OF 150,000RPM WITHOUT ANY ISSUES. NO ISSUES WERE NOTED DURING THE WET TEST. THE GUIDE WIRE WAS REMOVED WITH EASE FROM THE UNIT AFTER THE WET TEST. DURING ANALYSIS OF THE COMPLAINT UNIT NO ROTATIONAL SPEED ISSUES OR GUIDE WIRE RESTRICTION ISSUES WERE NOTED. IT WAS NOTED THAT THE BURR ANNULUS AND THE GUIDE WIRE SPRING TIP WERE DAMAGED. THE DAMAGE TO BOTH DEVICES IS CONSISTENT WITH THE BURR ANNULUS COMING INTO CONTACT WITH THE GUIDE WIRE SPRING TIP. THE ROTABLATOR DIRECTIONS FOR USE (DFU) WARNS THE USER NOT TO ALLOW THE BURR ANNULUS AND GUIDE WIRE TO COME INTO CONTACT. THE SHOP FLOOR PAPERWORK HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SHOP FLOOR PAPERWORK REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THIS COMPLAINT IS DETERMINED TO BE USER RELATED.

    Description of Event or Problem · 1

    REPORTABLE BASED UPON INVESTIGATION COMPLETED ON 2/26/2008. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTALINK PLUS CATHETER STALLED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE PROCEDURE, THE 1.25MM ROTALINK PLUS CATHETER KEPT STALLING, AND THE GUIDE WIRE BECAME STUCK IN THE ROTALINK PLUS CATHETER. THEREFORE, THE SYSTEM WAS REMOVED AND THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME. NO PATIENT STATUS IS LISTED AS "FINE." INVESTIGATION REVEALED THAT THE BURR ANNULUS WAS DAMAGED/BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 11290024

    Patients

    Seq Age Sex Outcome Treatment
    1