BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3200247 · Received July 1, 2013

    Report

    Report Number
    2134265-2013-04403
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 5, 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

    DEVICE EVALUATED BY MFR: 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2134265-2013-04893. SAME CASE AS MDR# 2134265-2013-04892. IT WAS REPORTED THAT DURING AN ABLATION TREATMENT PROCEDURE, THE BURR GOT STUCK IN THE LESION, DISSECTION OCCURRED, VESSEL BLOCKED AND THE PATIENT WAS SENT TO SURGERY. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE EXTREMELY ECCENTRIC LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN HAD DIFFICULTY ADVANCING A ROTAWIRE TO THE LESION. FINALLY THE ROTAWIRE WAS ABLE TO BE ADVANCED INTO THE 2ND DIAGONAL BRANCH. ATHERECTOMY WAS PERFORMED MULTIPLE TIMES USING 1.25MM AND 1.5MM ROTABLATOR BURRS, DISSECTION OCCURRED IN THE DIAGONAL. THE PHYSICIAN THEN PERFORMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT USING A 1.5MM UNSPECIFIED BALLOON RESULTING IN RESTORATION OF CONTRAST FLOW. MULTIPLE INFLATIONS OF THE PROXIMAL LAD STENOSIS WERE PERFORMED WITH INITIALLY GOOD RESULTS. AN UNSPECIFIED 2.0MM BALLOON WAS ADVANCED FOR FURTHER PRE-DILATATION BUT COULD NOT BE PLACED DUE TO RESIDUAL CALCIFICATION AT THE END OF THE INITIAL STENOSIS. THE 1.25MM ROTABLATOR WAS ADVANCED TO THE LESION FOR A SECOND TIME, THE BURR GOT STUCK IN THE LESION. MULTIPLE ATTEMPTS TO GET THE ROTATING BURR TO MOVE BACKWARDS FAILED RESULTING IN THE CATHETER TIP BEING PULLED INTO THE MAIN STEM. THE PATIENT RESPIRATORY RATE (RR) DROPPED SUDDENLY; CONTROL IMAGE SHOWS ACUTE OCCLUSION OF THE CIRCUMFLEX (CX) ARTERY BEHIND THE 90 DEGREE BRANCH-OFF. NO POSSIBILITY TO PROBE SHORT-TERM. THE PHYSICIAN PLACED AN UNSPECIFIED 10F SHEATH IN THE RIGHT FEMORAL ARTERY AND AN INTRA-AORTIC BALLOON PUMP WAS INSTALLED. STEADY AUGMENTATION OF THE INITIALLY VERY LOW RR WAS PERFORMED INCLUDING INTUBATION AND CONTROLLED VENTILATION. THE PATIENT WAS HEMODYNAMICALLY STABLE AND TRANSFERRED BY HELICOPTER TO CARDIAC SURGERY AT ANOTHER FACILITY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298240 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 15772225

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R