BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3052469 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02264
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE RETURNED DEVICE WAS CARRIED OUT. THE PLUS UNIT HANDSHAKE CONNECTIONS WERE CONNECTED TOGETHER. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE AND A CONNECT/DISCONNECT TEST WAS CARRIED OUT AS PER PROCEDURE. NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. THE BURR WAS MICROSCOPICALLY EXAMINED AND THE ANNULUS OF THE BURR WAS FOUND TO BE MISSHAPEN AND FLARED. NO ISSUES WERE NOTED WITH THE DIAMONDS OF THE BURR. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02874 & 2134265-2013-02875. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A SPIRAL DISSECTION OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY VIA AN UNSPECIFIED 6FR SHEATH. A 6FR Q 4.5 UNSPECIFIED (MACH1 OR RUNWAY) BSC GUIDE CATHETER WAS ADVANCED AND ANGIOGRAMS WERE OBTAINED. THE 67% STENOSED WITH A LUMINAL CROSS-SECTION OF 2.8MM TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND NON-TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AT THE MAJOR SEPTAL PERFORATOR. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE LESION WITH A CHOICE FLOPPY GUIDE WIRE. THE PHYSICIAN UTILIZED THE 1.25MM ROTABLATOR ROTALINK PLUS BURR FOR 2-3 ABLATION RUNS IN THE PROXIMAL LAD, CONTINUING WITH THE SAME BURR IN THE MID LAD. A SPIRAL DISSECTION WAS THEN NOTED, RETROGRADE INTO THE LEFT MAIN TRUNK AND AORTA, AND THE LAD VESSEL HAD SHUT DOWN. INTRACORONARY NITROGLYCERIN WAS ADMINISTERED AS WELL AS INTRACORONARY NIPRIDE. THE BURR WAS REMOVED, HOWEVER THE PHYSICIAN ADVANCED A 1.5MM UNSPECIFIED BALLOON IN AN ATTEMPT TO REMOVE THE ROTAWIRE GUIDE WIRE WITHOUT SUCCESS. FOLLOWING ADVANCEMENT OF A NON BSC GUIDE WIRE, THE BALLOON AND ROTAWIRE GUIDE WIRE WERE REMOVED. FLOW WAS NOTED DOWN THE LAD. FURTHER ANGIOGRAPHY REVEALED THE DISSECTION BACK INTO THE AORTA, WITH 99% OBSTRUCTION AT THE ORIGIN OF THE LAD AND STAINING IN THE AORTIC ROOT, AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO SURGERY. THE PATIENT REMAINED ASYMPTOMATIC WITHOUT ANY CHEST PAIN DURING THE PROCEDURE, NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS "STABLE AND PAIN FREE."

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02874 AND 2134265-2013-02875. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A SPIRAL DISSECTION OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY VIA AN UNSPECIFIED 6FR SHEATH. A 6FR Q 4.5 UNSPECIFIED (MACH1 OR RUNWAY) BSC GUIDE CATHETER WAS ADVANCED AND ANGIOGRAMS WERE OBTAINED. THE 67% STENOSED WITH A LUMINAL CROSS-SECTION OF 2.8MM TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND NON-TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AT THE MAJOR SEPTAL PERFORATOR. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE LESION WITH A CHOICE FLOPPY GUIDE WIRE. THE PHYSICIAN UTILIZED THE 1.25MM ROTABLATOR ROTALINK PLUS BURR FOR 2-3 ABLATION RUNS IN THE PROXIMAL LAD, CONTINUING WITH THE SAME BURR IN THE MID LAD. A SPIRAL DISSECTION WAS THEN NOTED, RETROGRADE INTO THE LEFT MAIN TRUNK AND AORTA, AND THE LAD VESSEL HAD SHUT DOWN. INTRACORONARY NITROGLYCERIN WAS ADMINISTERED AS WELL AS INTRACORONARY NIPRIDE. THE BURR WAS REMOVED, HOWEVER, THE PHYSICIAN ADVANCED A 1.5MM UNSPECIFIED BALLOON IN AN ATTEMPT TO REMOVE THE ROTAWIRE GUIDE WIRE WITHOUT SUCCESS. FOLLOWING ADVANCEMENT OF A NONBSC GUIDE WIRE, THE BALLOON AND ROTAWIRE GUIDE WIRE WERE REMOVED. FLOW WAS NOTED DOWN THE LAD. FURTHER ANGIOGRAPHY REVEALED THE DISSECTION BACK INTO THE AORTA, WITH 99% OBSTRUCTION AT THE ORIGIN OF THE LAD AND STAINING IN THE AORTIC ROOT, AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO SURGERY. THE PATIENT REMAINED ASYMPTOMATIC WITHOUT ANY CHEST PAIN DURING THE PROCEDURE, NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS "STABLE AND PAIN FREE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154408 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 15739613

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention