BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1834288 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04289
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE ROTAWIRE 325 CM FLOPPY GUIDEWIRE WAS RECEIVED IN TWO SECTIONS WITH DIAMETER REDUCTION NOTED AT THE FRACTURED SITES. SEM FRACTURE ANALYSIS CONCLUSIONS: FRACTURE OCCURRED IN A TORSION OVERLOAD DIRECTION DUE TO BURR INDUCED SURFACE WEAR. THE FRACTURE SURFACE EXHIBITED PRIMARILY ELONGATED DIMPLE RUPTURES IN A TORSION DIRECTION. NO OTHER MATERIAL ANOMALIES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE USER ERROR. PER THE DFU, "DO NOT ALLOW THE BURR TO REMAIN IN ONE LOCATION WHILE ROTATING AT HIGH SPEEDS, AS THIS MAY LEAD TO WEAR OF THE GUIDEWIRE. GENTLY ADVANCE OR RETRACT THE BURR WHILE IT IS IN HIGH-SPEED ROTARY MOTION". (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-04288. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 1.5MM ROTALINK PLUS UNIT WAS BEING SPEED TESTED PRIOR TO ENTERING THE BODY. DURING THE SPEED TEST THE FLOPPY ROTAWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-04288. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 1.5MM ROTALINK PLUS UNIT WAS BEING SPEED TESTED PRIOR TO ENTERING THE BODY. DURING THE SPEED TEST THE FLOPPY ROTAWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT 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 - MIAMI H802228240021

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5MM ROTALINK PLUS