BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ BURR

    MDR report key: 2760280 · Received September 26, 2012

    Report

    Report Number
    2134265-2012-06004
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A BURR COULD NOT BE REMOVED. THE 95% STENOSED, ECCENTRIC LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA), WITH AN ADDITIONAL 75% STENOSED LESION IN THE MID RCA. TIMI FLOW WAS 2 PRE-PROCEDURE. ANGIOPLASTY WAS UNSUCCESSFUL WITH A 2.5X15MM BALLOON, THEREFORE, THE PHYSICIAN CHOSE ROTABLATION. FOLLOWING ONE ABLATION PASS AT 150,000 RPMS FOR 57 SECONDS, THE 1.5MM ROTABLATOR BURR WENT THROUGH THE LESION AND COULD NOT BE REMOVED. THE PHYSICIAN ADVANCED AN UNSPECIFIED BALLOON AND MULTIPLE GUIDE WIRES IN ATTEMPTS TO LOOSEN THE BURR WITHOUT SUCCESS. THE PATIENT WAS RESTING COMFORTABLY WITH NO PAIN DURING THE RETRIEVAL ATTEMPTS. ANOTHER PHYSICIAN WAS ABLE TO REMOVE THE BURR. THE PROCEDURE CONTINUED WITH FURTHER ANGIOPLASTY WITH 1.5-3.0MM BALLOONS, DEPLOYMENT OF 2 PROMUS ELEMENT DRUG-ELUTING STENTS (3.0X38MM AND 3.5X38MM), AND POST-DILATION. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN FOR ONE YEAR AND PLAVIX. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 15372994

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention