BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3222650 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04912
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED SOLIDIFIED BLOOD WITHIN THE CATHETER SHEATH. THE SHEATH WAS TORN/SPLIT APPROXIMATELY 16CM FROM THE STRAIN RELIEF. NO ISSUE WAS NOTED WITH THE STRAIN RELIEF. A GUIDEWIRE WAS RETURNED WITHIN THE DEVICE AND COULD NOT BE REMOVED. THE BURR WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DIRECTIONS FOR USE (DFU) STATES: ADVANCE THE CATHETER THROUGH THE HEMOSTASIS VALVE AND GENTLY TIGHTEN THE VALVE TO PREVENT BLEEDING AROUND THE CATHETER SHEATH. 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. THEREFORE THE ROOT CAUSE HAS BEEN DETERMINED TO BE USER RELATED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE SYSTEM LEAKED. THE TARGET LESION WAS LOCATED IN UNSPECIFIED VESSEL. DURING THE PROCEDURE, IT WAS NOTICED SALINE WAS LEAKING FROM ONE SIDE OF THE 1.75MM ROTABLATOR ROTALINK PUS SYSTEM. THE PHYSICIAN COULD NOT REMOVE THE SYSTEM FROM THE GUIDEWIRE AND HAD TO REMOVE EVERYTHING TOGETHER. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED BALLOONS AND STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OKAY. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED A TEAR IN THE SHEATH APPROXIMATELY 16CM FROM THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322986 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 15903545

    Patients

    Seq Age Sex Outcome Treatment
    1