BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2770838 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05913
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-06110. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, A GUIDE WIRE FRACTURE AND BURR DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. THE PHYSICIAN NOTED THE LESION WAS VERY DIFFICULT TO CROSS WITH A VARIETY OF GUIDE WIRES BUT WAS FINALLY CROSSED WITH A NON BSC GUIDE WIRE. HOWEVER A BALLOON CATHETER WAS NOT ABLE TO BE DELIVERED OVER THIS WIRE. THE NON BSC GUIDE WIRE WAS REMOVED AND REPLACED WITH A ROTAWIRE FLOPPY GUIDE WIRE. THE PHYSICIAN ADVANCED A 1.25MM ROTALINK BURR TO THE LESION. DURING ABLATION IN THE DISTAL PORTION OF THE LESION, THE BURR STALLED AND FRACTURED THE BURR AND GUIDE WIRE. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE BURR UNSUCCESSFULLY. CARDIAC SURGERY WAS CONSULTED BUT IT WAS FELT THERE WAS VERY LITTLE CHANCE, IF ANY, OF SURGICALLY REMOVING THIS DEVICE. THE CIRCUMFLEX ARTERY WAS OCCLUDED WITH THE 3CM PIECE OF THE ROTALINK BURR AND APPEARED TO BE EMBEDDED IN THE ROOF OF THE LEFT MAIN. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND HAD NO ST SEGMENT ELEVATION. ST SEGMENT DEPRESSION IMPROVED ON INTRAVENOUS NITROGLYCERIN AND BETA BLOCKERS. DECISION WAS MADE TO NOT PERFORM EMERGENCY CARDIAC SURGERY AND JUST OBSERVE THE PATIENT IN THE CCU ON OPTIMAL MEDICAL THERAPY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 15427991

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention