BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1842784 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04387
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS MFR REPORT #: 2134265-2010-04388. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 35MM IN LENGTH. INITIALLY, THE PHYSICIAN ATTEMPTED TO PREDILATE THE LESION WITH AN UNSPECIFIED BALLOON CATHETER; HOWEVER, THIS WAS NOT SUCCESSFUL. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A NON-BSC PENETRATION CATHETER; HOWEVER, THAT WAS NOT SUCCESSFUL. THE PHYSICIAN CROSSED A NON-BSC MICROCATHETER, AND EXCHANGED THE NON-BSC GUIDE WIRE FOR A ROTAWIRE FLOPPY GUIDE WIRE. THE PHYSICIAN ADVANCED A 1.25MM ROTALINK PLUS BURR, AND SUCCESSFULLY COMPLETED 5 RUNS OF ABLATION FOR 10 SECONDS EACH RUN AT A SPEED OF 180,000 RPMS. THE PHYSICIAN THEN EXCHANGED THE SYSTEM FOR A 1.5MM ROTALINK PLUS BURR, AND COMPLETED 3 RUNS OF 10 SECONDS EACH RUN AT A SPEED OF 180,000. FOLLOWING THE USE OF THE 1.5MM BURR, CORONARY ANGIOGRAPHY WAS PERFORMED, AND THE PHYSICIAN NOTED THAT THE ROTAWIRE FLOPPY GUIDE WIRE HAD FRACTURED INTO TWO PIECES. THE PHYSICIAN USED A NON-BSC SNARE TO RETRIEVE 11 CM OF THE ROTAWIRE FLOPPY GUIDE WIRE; HOWEVER, THE DISTAL 1CM PORTION STILL REMAINS IN THE PATIENT IN THE DISTAL PORTION OF THE POSTERIOR DESCENDING ARTERY. TWO PROMUS STENTS WERE IMPLANTED IN THE PROXIMAL TO MID RCA. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    CORRECTION - IT WAS FURTHER REPORTED THAT THE PROMUS STENTS WERE IMPLANTED IN THE MID TO DISTAL RCA, NOT THE ORIGINALLY REPORTED PROXIMAL TO MID RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0013327171

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other LIFESPEAR 2.0 X6MM BALLOON CATHETER| HIRYU 2.5 X 10MM BALLOON CATHETER| 6FR RUNWAY FL4 GUIDE CATHETER| RUNTHROUGH GUIDE WIRE| TAZUNA 1.5 X 10MM BALLOON CATHETER| TERUMO FINE CROSS MICROCATHETER| ASAHI CORSAIR MICROCATHETER| ROTABLATOR ROTALINK PLUS 1.25MM| ROTAWIRE FLOPPY| WHISPER GUIDE WIRE| 6FR RUNWAY AL1 GUIDE CATHETER