BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2962352 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-01085
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    November 6, 2012
    Report Date
    January 25, 2013
    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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS A FRACTURE 193.8 CM FROM THE DISTAL END. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE FRACTURED SECTION WAS SENT TO THE (B)(4) FOR ANALYSIS. AS PER (B)(4) RESULTS THE FAILURE OCCURRED DUE TO A MECHANICAL CUT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ALL GATHERED INFORMATION HAS BEEN REVIEWED AND A ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, DEFORMATION OCCURRED. DURING PRE-TEST, OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED THE ROTAWIRE GUIDE WIRE APPEARED TO BE "LIFTED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE GUIDE WIRE FRACTURED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, DEFORMATION OCCURRED. DURING PRE-TEST, OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED THE ROTAWIRE GUIDE WIRE APPEARED TO BE "LIFTED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE GUIDE WIRE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65940 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - MIAMI H802232390010 14734682

    Patients

    Seq Age Sex Outcome Treatment
    1