BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK BURR

    MDR report key: 8114933 · Received November 29, 2018

    Report

    Report Number
    2134265-2018-63286
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 23, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DESCRIBE EVENT OR PROBLEM, MODEL NUMBER, CATALOG NUMBER, INITIAL REPORTER TITLE, INITIAL REPORTER PHONE, MFR SITE ADDRESS 2, MFR SITE STATE, MFR SITE ZIP/POST CODE AND EVALUATION CONCLUSION CODES. CORRECTED BRAND NAME FROM ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM TO ROTALINK BURR. CORRECTED INITIAL REPORTER FIRST NAME FROM (B)(6) TO (B)(6). CORRECTED INITIAL REPORTED LAST NAME FROM (B)(6) TO (B)(6). CORRECTED OCCUPATION FROM OTHER HEALTH CARE PROFESSIONAL TO PHYSICIAN. CORRECTED MFR SITE FACILITY NAME FROM BOSTON SCIENTIFIC CORPORATION TO BOSTON SCIENTIFIC CORK LIMITED. CORRECTED MFR SITE ADDRESS 1 FROM TWO SCIMED PLACE TO CORK BUSINESS TECHNOLOGY PARK. CORRECTED MFR SITE CITY FROM MAPLE GROVE TO CORK. CORRECTED MFR SITE COUNTRY FROM UNITED STATES TO IRELAND. THIS SUPPLEMENTAL CORRECTION REPORT IS BEING FILED TO CORRECT THE REPORT NUMBER IN A PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT (FOLLOW-UP NUMBER 001) WHICH WAS ACCEPTED BY FDA ON 12/26/2018 10:31 AM CT. THE REPORT NUMBER IS BEING CORRECTED FROM: 2134265-2018-64637 TO: 2134265-2018-63286.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ROTAWIRE FRACTURE OCCURRED. A 330CM ROTAWIRE AND 1.50MM ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR CAME IN CONTACT WITH THE DISTAL END OF THE ROTAWIRE AND LEFT APPROXIMATELY 3CM OF THE SEVERED WIRE BEHIND. THE PHYSICIAN ATTEMPTED TO SNARE THE REMAINDER OF THE DETACHED ROTAWIRE BUT WAS UNSUCCESSFUL. THE PATIENT WAS MONITORED AND WAS NOTED TO BE STABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS SATISFACTORY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS ABANDONED AND NOT COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROTAWIRE FRACTURE OCCURRED. A 330CM ROTAWIRE AND 1.50MM ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR CAME IN CONTACT WITH THE DISTAL END OF THE ROTAWIRE AND LEFT APPROXIMATELY 3CM OF THE SEVERED WIRE BEHIND. THE PHYSICIAN ATTEMPTED TO SNARE THE REMAINDER OF THE DETACHED ROTAWIRE BUT WAS UNSUCCESSFUL. THE PATIENT WAS MONITORED AND WAS NOTED TO BE STABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955345 ROTALINK BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3320

    Patients

    Seq Age Sex Outcome Treatment
    1