BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2020282 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00659
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED IN TWO SEPARATE PIECES, THE DISTAL AND PROXIMAL SEGMENTS OF THE WIRE FRACTURE. THE CORE WIRE WAS FRACTURED AT THE DISTAL END OF THE WIRE. THE SEM ANALYSIS RESULTS WERE THAT A FRACTURE OCCURRED IN A BENDING OVERLOAD DIRECTION AS A RESULT OF A REDUCTION IN THE CROSS-SECTIONAL AREA OF THE WIRE DUE TO SURFACE WEAR. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-00658. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL BRANCH OF THE LAD. AN ATTEMPT WAS MADE TO PERFORM IVUS WITH AN ATLANTIS SR PRO2 IVUS CATHETER, BUT IT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN EXCHANGED AN UNSPECIFIED GUIDE WIRE FOR A 330 CM FLOPPY ROTAWIRE GUIDE WIRE. SIX ABLATION PASSES WERE PERFORMED WITH A 1.5MM ROTALINK PLUS FOR 222,000 - 225,000 RPM'S FOR A LENGTH OF 8 - 10 SECONDS IN THE MAIN BRANCH OF THE LAD. THEN THE PHYSICIAN NOTICED THAT THE 1.5MM BURR WAS IN THE DIAGONAL BRANCH EVEN THOUGH THE ROTAWIRE GUIDE WIRE HAD NOT BEEN POSITIONED IN THE DIAGONAL BRANCH. IT WAS THEN DETERMINED THAT THE ROTAWIRE GUIDE WIRE WAS FRACTURED. NUMEROUS ATTEMPTS TO RETRIEVE THE DETACHED GUIDE WIRE WERE UNSUCCESSFUL. THE PATIENT WAS THEN SCHEDULED FOR BYPASS SURGERY AND THE DETACHED PORTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ACCORDING TO THE PHYSICIAN, THE MID PORTION OF THE SEPARATED WIRE BECAME KINKED OR BENT WHEN THE PHYSICIAN CAUGHT THE WIRE WITH A CLAMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-00658. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL BRANCH OF THE LAD. AN ATTEMPT WAS MADE TO PERFORM IVUS WITH AN ATLANTIS SR PRO2 IVUS CATHETER, BUT IT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN EXCHANGED AN UNSPECIFIED GUIDE WIRE FOR A 330 CM FLOPPY ROTAWIRE GUIDE WIRE. SIX ABLATION PASSES WERE PERFORMED WITH A 1.5MM ROTALINK PLUS FOR 222,000 - 225,000 RPM'S FOR A LENGTH OF 8 - 10 SECONDS IN THE MAIN BRANCH OF THE LAD. THEN THE PHYSICIAN NOTICED THAT THE 1.5MM BURR WAS IN THE DIAGONAL BRANCH EVEN THOUGH THE ROTAWIRE GUIDE WIRE HAD NOT BEEN POSITIONED IN THE DIAGONAL BRANCH. IT WAS THEN DETERMINED THAT THE ROTAWIRE GUIDE WIRE WAS FRACTURED. NUMEROUS ATTEMPTS TO RETRIEVE THE DETACHED GUIDE WIRE WERE UNSUCCESSFUL. THE PATIENT WAS THEN SCHEDULED FOR BYPASS SURGERY AND THE DETACHED PORTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ACCORDING TO THE PHYSICIAN, THE MID PORTION OF THE SEPARATED WIRE BECAME KINKED OR BENT WHEN THE PHYSICIAN CAUGHT THE WIRE WITH A CLAMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 13684469

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 1.5MM ROTALINK PLUS BURR| SR PRO2 IVUS CATHETER| MACH1 CMP3.0 GUIDING CATHETER| MEDIKIT INTRODUCER SHEATH