BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 4153037 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06121
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COMPLAINT UNIT WAS RETURNED CONNECTED TO THE CATHETER. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT AND NO ISSUES WERE NOTED. THE ADVANCER KNOB WAS LOCKED UPON RETURN IN A BACKWARD POSITION, IT WAS LOOSENED AND ADVANCED IN ORDER TO INSPECT THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. A HANDSHAKE CONNECTION TEST WAS ATTEMPTED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED. THE DRIVE SHAFT COIL AND SHEATH WERE INSPECTED AND THERE WAS NO DAMAGE NOTED. A GUIDE WIRE WAS RETURNED RUNNING THROUGH THE DEVICE. THE GUIDE WIRE WAS REMOVED FROM THE DEVICE WITH NO RESISTANCE ENCOUNTERED. THE COMPLAINT UNIT WAS WET TESTED. THE COMPLAINT UNIT WAS UNABLE TO REACH OPTIMUM SPEED AS THE DEVICE STALLED. THE COMPLAINT ADVANCER WAS DISMANTLED AND THE ULTEM WAS FOUND TO BE MELTED. THERE WAS CORROSION OF THE TURBINE BUT IT IS UNLIKELY THIS CONTRIBUTED TO THIS EVENT AS THE TURBINE COULD BE FREELY ROTATED BY HAND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE DFU STATES: "NEVER OPERATE THE ROTABLATOR ADVANCER WITHOUT SALINE INFUSION. FLOWING SALINE IS ESSENTIAL FOR COOLING AND LUBRICATING THE WORKING PARTS OF THE ADVANCER. OPERATION OF THE ADVANCER WITHOUT PROPER SALINE INFUSION MAY RESULT IN PERMANENT DAMAGE TO THE ADVANCER.¿ (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-06164. IT WAS REPORTED THAT A BURR STUCK IN LESION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE LONG DIFFUSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO DISTAL LAD. A 1.50 MM ROTALINK¿ PLUS AND A ROTAWIRE FLOPPY WERE SELECTED AND ADVANCED TO TREAT THE LESION. DURING 1ST TO 12TH ABLATION, THE BURR WAS MOVED BACK AND FORWARD CONSTANTLY. HOWEVER, ST-ELEVATION AND SLOW FLOW WERE NOTED ON THE 12TH ABLATION. DURING THE 13TH ABLATION, THE SPEED WAS DOWNED TO 7000 RPM AND THE BURR WAS PUSHED AND GOT STUCK IN DISTAL LAD. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. INFLATION OF A 1.2X6 MM AND 1.5X15 MM NON-BSC BALLOON CATHETERS WERE PERFORMED TO TREAT THE LESION IN MID TO DISTAL LAD. POST INFLATION, INTRAVASCULAR ULTRASOUND WAS PERFORMED TO MEASURE THE BLOOD VESSEL DIAMETER AND THE LESION LENGTH. ANOTHER VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY USING AN 8F NON-BSC GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO BAIL OUT IT WITH AN UNSPECIFIED BALLOON CATHETER, HOWEVER, AN UNSPECIFIED GUIDE WIRE WAS UNABLE TO ADVANCE. THE BURR WAS REMOVED TO THE PROXIMAL END OF LAD BUT IT GOT STUCK AGAIN. THE DEVICE WAS SUCCESSFULLY REMOVED BY ADVANCING A NON-BSC MICRO CATHETER, NON-BSC GUIDE WIRE, A 1MM X 10MM NON-BSC BALLOON CATHETER, ANOTHER NON-BSC BALLOON CATHETER. CALCIFICATION WAS TREATED WITH A 2.75X15MM NON-BSC BALLOON CATHETER AND IMPLANTATION OF A 3.0X38MM AND 3.5X34MM NON BSC STENTS. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-06164. IT WAS REPORTED THAT A BURR STUCK IN LESION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE LONG DIFFUSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO DISTAL LAD. A 1.50 MM ROTALINK¿ PLUS AND A ROTAWIRE FLOPPY WERE SELECTED AND ADVANCED TO TREAT THE LESION. DURING 1ST TO 12TH ABLATION, THE BURR WAS MOVED BACK AND FORWARD CONSTANTLY. HOWEVER, ST-ELEVATION AND SLOW FLOW WERE NOTED ON THE 12TH ABLATION. DURING THE 13TH ABLATION, THE SPEED WAS DOWNED TO 7000 RPM AND THE BURR WAS PUSHED AND GOT STUCK IN DISTAL LAD. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. INFLATION OF A 1.2X6 MM AND 1.5X15 MM NON-BSC BALLOON CATHETERS WERE PERFORMED TO TREAT THE LESION IN MID TO DISTAL LAD. POST INFLATION, INTRAVASCULAR ULTRASOUND WAS PERFORMED TO MEASURE THE BLOOD VESSEL DIAMETER AND THE LESION LENGTH. ANOTHER VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY USING AN 8F NON-BSC GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO BAIL OUT IT WITH AN UNSPECIFIED BALLOON CATHETER, HOWEVER, AN UNSPECIFIED GUIDE WIRE WAS UNABLE TO ADVANCE. THE BURR WAS REMOVED TO THE PROXIMAL END OF LAD BUT IT GOT STUCK AGAIN. THE DEVICE WAS SUCCESSFULLY REMOVED BY ADVANCING A NON-BSC MICRO CATHETER, NON-BSC GUIDE WIRE, A 1MM X 10MM NON-BSC BALLOON CATHETER, ANOTHER NON-BSC BALLOON CATHETER. CALCIFICATION WAS TREATED WITH A 2.75X15MM NON-BSC BALLOON CATHETER AND IMPLANTATION OF A 3.0X38MM AND 3.5X34MM NON BSC STENTS. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632153 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 17131167

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDING CATHETER:LAUNHER EBU3.5SH