BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3241524 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05262
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: UNIT RETURNED IN A GENERIC PLASTIC BAG. THE UNIT WAS RECEIVED SEPARATED IN TWO SECTIONS AND ONE SECTION WAS RECEIVED LOADED IN THE ROTABLATOR CATHETER, THE WIRE RETURNED IS KINKED, AS PART OF OVERALL VISUAL REVISION. THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE RETURNED FRACTURED IN TWO SECTIONS; THE PART#1 (PROXIMAL) RETURNED INSIDE THE CATHETER AND IS KINKED ALONG THE BODY; AND THE PART#2 (DISTAL) PRESENTED THE PROXIMAL END KINKED. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. MEASUREMENTS WERE TAKEN WITH DIGITAL MICROMETER. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE (B)(4) LAB RETURNED THE FOLLOWING RESULTS: FAILURE ON BOTH SAMPLES OCCURRED DUE TO A CYCLE 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 DUE TO PROCEDURAL/ANATOMICAL FACTORS DURING THE PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A DISTAL TIP KINKED OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A ROTAWIRE EXTRA SUPPORT GUIDE WIRE WAS SELECTED TO TREAT THE TARGET LESION. DURING PROCEDURE IT WAS NOTED THAT THE TIP OF THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, ADDITIONAL INFORMATION REVEALED THAT THE GUIDE WIRE WAS SEPARATED IN TWO SECTION.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A DISTAL TIP KINKED OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A ROTAWIRE EXTRA SUPPORT GUIDE WIRE WAS SELECTED TO TREAT THE TARGET LESION. DURING PROCEDURE IT WAS NOTED THAT THE TIP OF THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, ADDITIONAL INFORMATION REVEALED THAT THE GUIDE WIRE WAS SEPARATED IN TWO SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340423 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802232390010 15644247

    Patients

    Seq Age Sex Outcome Treatment
    1