BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1982876 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00181
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL AND TACTILE INSPECTION REVEALED A FRACTURE NEAR THE DISTAL END AND THE SPRING TIP IS MISSING. THE OUTER DIAMETER MEASUREMENTS WERE MEASURED AND MET SPECIFICATIONS. A SEM LAB ANALYSIS WAS PREFORMED AND IT CONCLUDED THAT THE FRACTURE WAS DUE TO A BENDING OVERLOAD. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-00289 AND 2134265-2011-00454. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ADVANCED THE 325CM ROTAWIRE GUIDE WIRE AND THE 1.5MM ROTALINK BURR TO THE LESION AND BEGAN ABLATION. TWO ABLATION PASSES WERE COMPLETED WHEN THE ROTAWIRE FRACTURED. NO GUIDE WIRE FRAGMENT WAS LEFT IN PATIENT AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN THEN ADVANCED ANOTHER 325CM ROTAWIRE TO THE LESION AND DURING THE FOURTH ABLATION PASS THE BURR CAME INTO CONTACT WITH THE ROTAWIRE AND THE RADIOPAQUE PORTION OF THE TIP BROKE FROM THE WIRE. THE PHYSICIAN MADE A DECISION NOT TO RETRIEVE THE WIRE FRAGMENT AND THE FRAGMENT WAS LEFT IN THE DISTAL CX ARTERY. THE PROCEDURE WAS COMPLETED WITH A 3.5MM NON-BSC BALLOON AND THE DEPLOYMENT OF A 3.25MM NON-BSC STENT. THE WIRE FRAGMENT WAS NOT STENTED TO THE WALL OF THE VESSEL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-00289 AND 2134265-2011-00454. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ADVANCED THE 325CM ROTAWIRE GUIDE WIRE AND THE 1.5MM ROTALINK BURR TO THE LESION AND BEGAN ABLATION. TWO ABLATION PASSES WERE COMPLETED WHEN THE ROTAWIRE FRACTURED. NO GUIDE WIRE FRAGMENT WAS LEFT IN PATIENT AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN THEN ADVANCED ANOTHER 325CM ROTAWIRE TO THE LESION AND DURING THE FOURTH ABLATION PASS THE BURR CAME INTO CONTACT WITH THE ROTAWIRE AND THE RADIOPAQUE PORTION OF THE TIP BROKE FROM THE WIRE. THE PHYSICIAN MADE A DECISION NOT TO RETRIEVE THE WIRE FRAGMENT AND THE FRAGMENT WAS LEFT IN THE DISTAL CX ARTERY. THE PROCEDURE WAS COMPLETED WITH A 3.5MM NON-BSC BALLOON AND THE DEPLOYMENT OF A 3.25MM NON-BSC STENT. THE WIRE FRAGMENT WAS NOT STENTED TO THE WALL OF THE VESSEL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 13670811

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other ROTAWIRE GUIDE WIRE, 325CM/FLOP| ROTALINK BURR, 1.5MM