BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK (TM) PLUS

    MDR report key: 2203180 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03596
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON VISUAL EXAMINATION IT WAS NOTED THAT THE HANDSHAKE CONNECTION OF THE CATHETER UNIT WAS DETACHED/SEPARATED FROM THE DEVICE. THE DRIVE SHAFT WAS BROKEN. NO ISSUES WERE NOTED WITH THE CATHETER SHEATH. THE ROTABLATOR PLUS COULD NOT BE WET TESTED DUE TO THE DAMAGED HANDSHAKE CONNECTION OF THE CATHETER UNIT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SHEATH DAMAGE OCCURRED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. WHILE PREPPING THE 1.75MM ROTABLATOR BURR CATHETER, THE DEVICE MADE A STRANGE NOISE AND THE DRIVE SHAFT SHEATH BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER BURR CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SHEATH DAMAGE OCCURRED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. WHILE PREPPING THE 1.75MM ROTABLATOR BURR CATHETER, THE DEVICE MADE A STRANGE NOISE AND THE DRIVE SHAFT SHEATH BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER BURR CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SHEATH DAMAGE OCCURRED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. WHILE PREPPING THE 1.75MM ROTABLATOR BURR CATHETER, THE DEVICE MADE A STRANGE NOISE AND THE DRIVE SHAFT SHEATH BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER BURR CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK (TM) PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 0014399144

    Patients

    Seq Age Sex Outcome Treatment
    1