BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? BURR

    MDR report key: 3254798 · Received July 30, 2013

    Report

    Report Number
    2134265-2013-05261
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 3, 2013
    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

    LITERATURE CITATION: SULIMOV, DS ET AL. (2013). STUCK ROTABLATOR: THE NIGHTMARE OF ROTATIONAL ATHERECTOMY. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HIDEAKI KANEDA. TRAPPED ROTABLATOR:KOKESI PHENOMENON. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 49:82-84 (2000). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THE ROTABLATOR BURR STUCK IN THE VESSEL. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING ABLATION USING A 1.75MM ROTABLATOR BURR, THE BURR STUCK IN THE VESSEL AND REQUIRED SURGICAL REMOVAL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED: THE RIGHT CORONARY ARTERY WAS FIRST TREATED WITH AVE GFX STENT. ONE MONTH LATER, THE PATIENT WAS TO UNDERGO TREATMENT WITH THE ROTABLATOR OF THE NARROWING OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE REFERENCE DIAMETER OF THE PROXIMAL SITE OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS 2.49 MM AND THE MINIMUM LUMEN DIAMETER OF THE PROXIMAL NARROWING WAS 0.54 MM AND THE DISTAL WAS 0.47 MM MEASURED BY QUANTITATIVE CORONARY ANGIOGRAM. AN 8FR GUIDING CATHETER WITH SIDE HOLES WAS INSERTED THROUGH THE RIGHT FEMORAL ARTERY AND 10,000 UNITS OF HEPARIN AND 5 MG ISOSORBIDE DINITRATE WERE GIVEN. A 0.009 ROTAWIRE FLOPPY GUIDEWIRE WAS CROSSED THROUGH THE NARROWING WITH THE AID OF A 2.75 MM OVER-THE-WIRE RANGER PTCA BALLOON. THE BALLOON WAS CHOSEN TO BE USED FOR BACKUP AND DILATATION AFTER ABLATION. THE PHYSICIAN TRIED TO ABLATE THE NARROWING, USING A 1.25 MM ROTABLATOR BURR WITH 160,000 RPM (BURR-TO-ARTERY RATIO 0.5) WITH A COCKTAIL INFUSION OF VERAPAMIL, ISOSORBIDE DINITRATE, AND HEPARIN MIXED IN PRESSURIZED SALINE. THE STARTING SITE WAS 10 MM PROXIMAL TO THE LESION. THE METHOD OF BURR ADVANCEMENT WAS A PECKING MOTION AND ABLATION TIME PER SESSION WAS LESS THAN 15 SEC. BECAUSE THE BURR WOULD NOT GO THROUGH IN TWO SESSIONS WITH A DECREMENT OF ABOUT 10,000 RPM, THE CYCLE PER MINUTE WAS INCREASED TO 180,000. ANOTHER TWO SESSIONS WITH 180,000 RPM WAS ALSO UNSUCCESSFUL WITH A DECREMENT OF ABOUT 10,000 RPM. THEREFORE, THE CYCLE PER MINUTE WAS INCREASED TO 200,000. AFTER THE INITIAL PASSAGE OF THE BURR, THE BURR WAS TRAPPED IN THE DISTAL PORTION OF THE PROXIMAL NARROWING, ALTHOUGH THE BURR COULD BE ROTATED. THE BURR COULD BE ROTATED TRANSIENTLY AND THE CYCLE PER MINUTE COULD NOT BE MEASURED. ANTEGRADE CORONARY FLOW WAS RESERVED. TO RELIEVE SPASM AND INCREASE ANTEGRADE CORONARY FLOW, 5 MG ISOSORBIDE DINITRATE AND 0.25 MG VERAPAMIL WAS GIVEN INTRACORONARILY. AS GLYCOPROTEIN IIB/IIIA INHIBITORS ARE NOT PERMITTED IN (B)(6), 5,000 UNITS OF HEPARIN WAS ADDED TO PREVENT THROMBOSIS. TO RETRIEVE THE BURR, AN ATTEMPT TO CROSS ANOTHER PTCA GUIDEWIRE AND PTCA BALLOON BUT NEITHER COULD GET PASSED THE BURR. AS THE PHYSICIANS ATTEMPTS COULD NOT RETRIEVE THE BURR WITH OFF-DYNAGLIDE (WITH TRANSIENT ROTATION), AN INTRAAORTIC BALLOON PUMPING WAS PERFORMED, RESULTING IN AN EMERGENCY SURGERY. THE BURR WAS RETRIEVED AFTER THE RESECTION OF THE PULMONARY ARTERY, THE LEFT MAIN CORONARY ARTERY, AND THE PROXIMAL SITE OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH AN ENDOARTERECTOMY OF THE SITE. THE PROXIMAL NARROWING WAS NOT ABLATED BY THE ROTABLATOR. SAPHENOUS VEIN GRAFTING WAS DONE FROM THE AORTA TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND THE DIAGONAL BRANCH. THE PATIENT HAD AN UNEVENTFUL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355217 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680020

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention