BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2990909 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01259
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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 MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THAT THE SHEATH HAD TIGHTENED MARKS 83CM AND 85CM FROM THE DISTAL TIP OF THE BURR. THIS IS CONSISTENT WITH OVER TIGHTENING OF THE HEMEOSTASIS VALVE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DIRECTIONS FOR USE GIVE DETAILED INSTRUCTIONS ON THE PROPER SET UP OF THE ROTABLATOR SYSTEM AND STATES TO AVOID EXCESSIVELY TIGHTENING THE HEMOSTASIS VALVE. THE DAMAGE FOUND ON THE RETURNED DEVICE IS CONSISTENT WITH OVER TIGHTENING OF THE HEMOSTASIS VALVE; THEREFORE, USER RELATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, A SHAFT LEAK OCCURRED. THE TARGET LESION IS UNKNOWN. DURING PREPARATION OF THE 1.5MM ROTABLATOR ROTALINK PLUS BURR, SALINE WAS INJECTED INTO THE DEVICE AND LEAKED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95098 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15623942

    Patients

    Seq Age Sex Outcome Treatment
    1