BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ BURR

    MDR report key: 2831580 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07041
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE BURR OF THE CATHETER UNIT WAS DETACHED FROM THE CATHETER AND WAS RETURNED SEPARATE TO THE DEVICE. THE DISTAL COIL OF THE CATHETER DEVICE WAS STRETCHED. THE BURR WAS MICROSCOPICALLY EXAMINED AND FOUND THE ANNULUS AND PROXIMAL END OF THE BURR WAS WITHIN SPECIFICATION. THERE WAS NO COIL INSIDE THE PROXIMAL END OF THE BURR AND THE EDGING APPEARING FLARED. THE COIL WAS MICROSCOPICALLY EXAMINED. IT WAS NOTED THAT THE DISTAL COIL WAS STRETCHED. 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. BSC ID A00360513: TW#2639648

    Additional Manufacturer Narrative · 1

    (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 PLATFORMING FOR A ROTATIONAL ATHERECTOMY PROCEDURE, THE BURR DETACHED. THE PHYSICIAN WAS RUNNING A PLATFORM TEST ON A 1.5MM ROTALINK BURR OUTSIDE OF THE PATIENT, THE BURR DETACHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLATFORMING FOR A ROTATIONAL ATHERECTOMY PROCEDURE, THE BURR DETACHED. THE PHYSICIAN WAS RUNNING A PLATFORM TEST ON A 1.5MM ROTALINK BURR OUTSIDE OF THE PATIENT, THE BURR DETACHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 15261172

    Patients

    Seq Age Sex Outcome Treatment
    1