BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK (TM) PLUS

    MDR report key: 2221229 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03690
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETUNED DEVICE FOUND THAT THE DEVICE HAS BEEN USED AS THERE WAS BLOOD PRESENT IN THE CATHETER. A ROTAWIRE WAS FOUND TO BE STUCK IN THE CATHETER AND COULD NOT BE REMOVED. 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 ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A BURR BECOME STUCK IN THE LESION. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY (LCX). A 1.25MM ROTALINK BURR WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE MAXIMUM ROTATIONAL SPEED WAS 155,000 RPM'S. ON THE FIRST ABLATION, AT A ROTATIONAL SPEED OF 135,000 RPM'S THE BURRS BECOME STUCK IN THE DISTAL LCX. THIS PREVENTED THE BURR FROM MOVING FORWARD OR BACKWARD. THE PHYSICIAN WAS ABLE TO REMOVE THE BURR FROM THE LESION BY DEEP SEATING THE GUIDE CATHETER AND PULLING BACK. ANGIOGRAPHY CONFIRMED NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNKNOWN BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS CURRENTLY DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A BURR BECOME STUCK IN THE LESION. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY (LCX). A 1.25MM ROTALINK BURR WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE MAXIMUM ROTATIONAL SPEED WAS 155,000 RPM'S. ON THE FIRST ABLATION, AT A ROTATIONAL SPEED OF 135,000 RPM'S THE BURRS BECOME STUCK IN THE DISTAL LCX. THIS PREVENTED THE BURR FROM MOVING FORWARD OR BACKWARD. THE PHYSICIAN WAS ABLE TO REMOVE THE BURR FROM THE LESION BY DEEP SEATING THE GUIDE CATHETER AND PULLING BACK. ANGIOGRAPHY CONFIRMED NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNKNOWN BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK (TM) PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0013279473

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention