BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2904223 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08337
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: DEVICE EVALUATED BY MFR, METHOD, RESULTS, AND CONCLUSION. DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE HANDSHAKE CONNECTIONS WERE CONNECTED TOGETHER. A TUG TEST WAS PERFORMED AND NO ISSUES WERE NOTED WITH THE UNIT'S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. THE BURR WAS MICROSCOPICALLY EXAMINED AND DRIED SALINE WAS FOUND ON THE BURR. THE ANNULUS OF THE BURR WAS FOUND TO BE SLIGHTLY MISSHAPEN. NO ISSUES WERE NOTED WITH THE DIAMONDS OF THE BURR. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, REMOVAL DIFFICULTY AND VESSEL PERFORATION OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A 1.5MM ROTABLATOR ROTALINK PLUS BURR TO THE LESION AND PERFORMED ABLATION. UPON ATTEMPTING TO REMOVE THE DEVICE, IT WAS NOTICED THE BURR WAS STUCK IN THE DISTAL PORTION OF THE LESION. THE PHYSICIAN REMOVED THE BURR, VESSEL PERFORATION WAS NOTED. THE PHYSICIAN USED AN UNKNOWN BALLOON CATHETER AND UNKNOWN COILS TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, REMOVAL DIFFICULTY AND VESSEL PERFORATION OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A 1.5MM ROTABLATOR ROTALINK PLUS BURR TO THE LESION AND PERFORMED ABLATION. UPON ATTEMPTING TO REMOVE THE DEVICE, IT WAS NOTICED THE BURR WAS STUCK IN THE DISTAL PORTION OF THE LESION. THE PHYSICIAN REMOVED THE BURR, VESSEL PERFORATION WAS NOTED. THE PHYSICIAN USED AN UNKNOWN BALLOON CATHETER AND UNKNOWN COILS TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10323 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15469703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention