BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 11349790 · Received February 19, 2021

    Report

    Report Number
    2134265-2021-01584
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    April 23, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOGOMONIAN, R., LIU, K., HAFTEVANI, E. A., AND GOWDA, R. M. (2020). INTRA-AORTIC BALLOON PUMP ENTRAPMENT WITHOUT RUPTURE: A CASE SERIES. FUTURE CARDIOLOGY, 16 (5), PP. 425-432.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUDDEN ONSET OF TYPICAL CHEST PAIN. VITAL SIGNS WERE SIGNIFICANT FOR A BLOOD PRESSURE OF 85/45 MMHG, HEART RATE OF 93 BEATS PER MINUTE (BPM), RESPIRATORY RATE OF 18, AND AN OXYGEN SATURATION OF 99% ON ROOM AIR. PATIENT WAS IN MILD DISTRESS WITH NORMAL HEART AND LUNG SOUNDS. THE PATIENT'S TROPONIN WAS FOUND TO BE ELEVATED TO 0.036 NG/ML, THEN 0.016 NG/ML SEVEN HOURS LATER ALONG WITH RESOLUTION OF ADMISSION SYMPTOMS. ECG REVEALED A NORMAL SINUS RHYTHM AT A RATE OF 88 BPM. A PRIOR CORONARY ANGIOGRAM REVEALED A 90-95% OCCLUSION OF THE RIGHT CORONARY ARTERY (RCA) TWO MONTHS PRIOR THAT WAS MEDICALLY MANAGED DUE TO TECHNICALLY DIFFICULT, SEVERELY CALCIFIED, AND TORTUOUS VESSEL. THE PATIENT WAS INITIALLY TREATED AS A NON-STEMI AND PLANNED FOR ROTATIONAL ATHERECTOMY FOLLOWED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING TRANS-RADIAL APPROACH. DURING THE FIRST PASS OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM, THE PATIENT DEVELOPED TRANSIENT SLOW FLOW AND SUBSEQUENT HEMODYNAMIC INSTABILITY AND THIRD-DEGREE ATRIOVENTRICULAR HEART BLOCK, REQUIRING TEMPORARY TRANSVENOUS PACING AND INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT. IN ALL SUBSEQUENT CASES, APPROPRIATE PRECAUTIONS FOR BALLOON PUMP INSERTION WERE SUCCESSFULLY PERFORMED. A SHEATHED INSERTION TECHNIQUE WAS PERFORMED WITH AN 8F SHEATH FOR INSERTION OF THE IABP. APPROPRIATE FUNCTION AND POSITIONING OF THE IABP WAS CONFIRMED WITH FLUOROSCOPY. REVASCULARIZATION OF THE RC WITH PLACEMENT OF A DRUG-ELUTING STENT WAS SUCCESSFULLY PERFORMED. THE PATIENT REQUIRED A SHORT STAY IN THE CORONARY CARE UNIT (CCU) WITH DOPAMINE INFUSION SUPPORT. REMOVAL OF THE IABP AT BESIDE IN THE CCU WITH CAREFUL TECHNIQUE AND CARE WAS COMPLICATED BY ENTRAPMENT AND RESISTANCE LIKELY DUE TO SEVERE CALCIFICATION. UNDER FLUOROSCOPY GUIDANCE, THE IABP WAS REMOVED AND THIS WAS COMPLICATED BY A LEFT FEMORAL ARTERY TEAR AND PERFORATION. HEMOSTASIS OF THE GROIN ACCESS SITE WAS ACHIEVED WITH MANUAL PRESSURE. THE PATIENT REQUIRED FIVE UNITS OF PACKED RED BLOOD CELLS, ONE UNIT OF PLATELETS, AND FRESH FROZEN PLASMA OVER THE NEXT 24 HOURS AN REMAINED HEMODYNAMICALLY STABLE. ON DAY TWO, IMAGING REVEALED A 1.3 X 1.6 CM PSEUDOANEURYSM. INTERVENTIONAL RADIOLOGY WAS CONSULTED; SUCCESSFUL THROMBIN INJECTION WAS PERFORMED FOR TREATMENT OF THE PSEUDOANEURYSM. THE PATIENT CONTINUED TO IMPROVE WITHOUT FURTHER SIGNS OF BLEEDING OR ISCHEMIA AND WAS DISCHARGED ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249798 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R