BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3073553 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02552
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER UPDATE FROM BATCH_UNKNOWN TO 0015903541. DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE, DEVICE AVAIL. FOR EVALUATION, RETURNED TO MANUFACTURER ON, DEVICE RETURNED TO MANUFACTURE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE PLUS UNIT WAS RETURNED TO SITE CONNECTED TOGETHER. THE RELATED GUIDEWIRE WAS RETURNED PARTIALLY WITHIN THE ROTABLATOR PLUS UNIT. A TUG TEST AND CONNECT/DISCONNECT TEST WERE PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTIONS. AN ATTEMPT WAS MADE TO LOAD A GUIDEWIRE ONTO THE PLUS UNIT USING A TEST GUIDE WIRE. RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. THE BURR WAS MICROSCOPICALLY EXAMINED AND THE BURR WAS FOUND TO BE CORRODED AND THE BURR ANNULUS WAS MISSHAPEN. THE EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR WAS WITHIN SPECIFICATION. A SCRATCH TEST WAS PERFORMED AND THE BURRS CUTTING ACTION WAS ACCEPTABLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. THE DFU STATES "THE ROTABLATOR SYSTEM IS CAPABLE OF TRANSMITTING ROTARY MOTION AT SPEEDS UP TO 190,000 RPM" AND "NEVER ADVANCE THE ROTATING BURR TO THE POINT OF CONTACT WITH THE GUIDEWIRE SPRING TIP. SUCH CONTACT COULD RESULT IN DISTAL DETACHMENT AND EMBOLIZATION OF THE TIP." (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATION 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

    SAME CASE AS MFR: 34265-2013-02544. IT WAS REPORTED THAT DURING A PERCUTANEOUS ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, CONCENTRIC SHAPED, 10MM IN LENGTH, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATED. A 330 CM ROTAWIRE FLOPPY GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. THEN A 1.25MM ROTALINK PLUS WAS SELECTED AND WAS LOADED ONTO THE 330 CM ROTAWIRE GUIDE WIRE. AN ATTEMPT WAS MADE TO PLATFORM THE DEVICE OUTSIDE THE PATIENT; HOWEVER, THE ROTABLATOR CONSOLE HAD BEEN LEFT SET AT APPROXIMATELY 250,00 RPM, THE TECHNICIAN TRIED TO LOWER THE RPM SPEED, BUT DURING THIS TIME THE ROTAWIRE GUIDE WIRE SNAPPED AT THE VERY TIP OF THE BURR. IT WAS FURTHER REPORTED THAT IT TOOK APPROXIMATELY 15-20 SECONDS FOR THE SPEED TO BE LOWERED AND APPROXIMATELY 120CM OF THE DISTAL END REMAINED. IT WAS UNCLEAR AS TO WHETHER THERE WAS A KINK IN THE ROTAWIRE GUIDE WIRE AT THE POINT OF THE BREAK. THE BROKEN PORTION OF THE ROTAWIRE GUIDE WIRE WHICH WAS OUTSIDE THE PATIENT WAS LEFT INSIDE THE ROTALINK PLUS. THE PORTION OF THE ROTAWIRE THAT REMAINED IN THE PATIENT WAS REMOVED. IT WAS NOTED THAT THE ROTAWIRE GUIDE WIRE WAS INSIDE THE PATIENT DURING PLATFORMING. THE VESSEL WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR: 34265-2013-02544. IT WAS REPORTED THAT DURING A PERCUTANEOUS ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, CONCENTRIC SHAPED, 10MM IN LENGTH, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATED. A 330 CM ROTAWIRE FLOPPY GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. THEN A 1.25MM ROTALINK PLUS WAS SELECTED AND WAS LOADED ONTO THE 330 CM ROTAWIRE GUIDE WIRE. AN ATTEMPT WAS MADE TO PLATFORM THE DEVICE OUTSIDE THE PATIENT; HOWEVER, THE ROTABLATOR CONSOLE HAD BEEN LEFT SET AT APPROXIMATELY 250,00RPM, THE TECHNICIAN TRIED TO LOWER THE RPM SPEED, BUT DURING THIS TIME THE ROTAWIRE GUIDE WIRE SNAPPED AT THE VERY TIP OF THE BURR. IT WAS FURTHER REPORTED THAT IT TOOK APPROXIMATELY 15-20 SECONDS FOR THE SPEED TO BE LOWERED AND APPROXIMATELY 120CM OF THE DISTAL END REMAINED. IT WAS UNCLEAR AS TO WHETHER THERE WAS A KINK IN THE ROTAWIRE GUIDE WIRE AT THE POINT OF THE BREAK. THE BROKEN PORTION OF THE ROTAWIRE GUIDE WIRE WHICH WAS OUTSIDE THE PATIENT WAS LEFT INSIDE THE ROTALINK PLUS. THE PORTION OF THE ROTAWIRE THAT REMAINED IN THE PATIENT WAS REMOVED. IT WAS NOTED THAT THE ROTAWIRE GUIDE WIRE WAS INSIDE THE PATIENT DURING PLATFORMING. THE VESSEL WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174653 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0015903541

    Patients

    Seq Age Sex Outcome Treatment
    1