BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2003297 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00409
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE UNIT WAS NOT RETURNED; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2011-00494 IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A DISSECTION OCCURRED. ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS APPROXIMATELY 20MM IN LENGTH. . FOLLOWING ADVANCEMENT OF THE FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN COMPLETED 5-6 ABLATION RUNS AT 169,000 TO 175,000 RPMS WITH THE 1.25MM BURR. THE PHYSICIAN REMOVED THE 1.25MM IN PREPARATION FOR AN EXCHANGE TO A 1.5MM BURR, AND NOTED THAT THE FLOPPY ROTAWIRE GUIDE WIRE WAS NOT IN THE LUMEN. THE GUIDE WIRE HAD STRAIGHTENED OUT AT A 90 DEGREE ANGLE OF THE VESSEL AND APPEARED TO BE SUB-INTIMAL. THERE WAS NO STAINING AT THE LOCATION OF THE DISSECTION, RATHER IT APPEARED TO BE A SLIT-TYPE OF DISSECTION. THE PATIENT HAD NO ADVERSE SYMPTOMS. THE PHYSICIAN THEN PLACED THREE PROMUS STENTS ACROSS THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention ROTALINK BURR 1.25MM