BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3770442 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02417
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. A TUG TEST WAS ATTEMPTED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED. THE COMPLAINT UNIT WAS ATTEMPTED TO BE WET TESTED. UPON INSPECTION IT WAS NOTED THERE WAS A TEAR IN THE SHEATH AROUND THE DISTAL COIL AND THAT SALINE WAS NOT REACHING THE END OF THE SHEATH BUT WAS BEING EXPELLED THROUGH THE SHEATH. 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-02415. IT WAS REPORTED THAT A SHEATH RUPTURED. A 1.50MM ROTALINK¿ PLUS WAS SELECTED TO TREAT THE TARGET LESION. DURING USE, IT WAS NOTED THERE WAS A RUPTURE OF THE SHEATH. THE SAME ISSUE OCCURRED WITH A SECOND 1.50MM ROTALINK¿ PLUS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-02415. IT WAS REPORTED THAT A SHEATH RUPTURED. A 1.50MM ROTALINK PLUS WAS SELECTED TO TREAT THE TARGET LESION. DURING USE, IT WAS NOTED THERE WAS A RUPTURE OF THE SHEATH. THE SAME ISSUE OCCURRED WITH A SECOND 1.50MM ROTALINK PLUS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249786 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0016543554

    Patients

    Seq Age Sex Outcome Treatment
    1