BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAWIRE? DRIVE AND WIRECLIP? TORQUER

    MDR report key: 25048046 · Received April 30, 2026

    Report

    Report Number
    2124215-2026-23511
    Event Type
    Death
    Date Received
    April 30, 2026
    Date of Event
    October 1, 2016
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729996231
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: EARLIEST POSSIBLE DATE OF EVENT AS THE PATIENT WERE ADMITTED FOR ELECTIVE PCI OCTOBER 2016 TO JUNE 2023. B2 DATE OF DEATH: EARLIEST POSSIBLE DATE OF DEATH AS THE PATIENT WERE ADMITTED FOR ELECTIVE PCI OCTOBER 2016 TO JUNE 2023. E1 INITIAL REPORTER PHONE: (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC, BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. WU, X., WU, M., HUANG, H. ET AL. PREDICTIVE VALUE OF THE CHA2DS2 VASC HSF SCORE FOR SLOW FLOW DURING ROTATIONAL ATHERECTOMY IN PATIENTS WITH SEVERE CORONARY ARTERY CALCIFICATION. BMC CARDIOVASC DISORD 25, 469 (2025). HTTPS://DOI.ORG/10.1186/S12872-025-04931-1

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE PATIENT DEATH OCCURRED. SLOW FLOW IS A FREQUENT COMPLICATION OF ROTATIONAL ATHERECTOMY (RA) FOR SEVERE CORONARY ARTERY CALCIFICATION (CAC), YET EFFECTIVE PREPROCEDURAL RISK STRATIFICATION TOOLS ARE LACKING. THE CHA2DS2 VASC HSF SCORE INCORPORATES MULTIPLE CARDIOVASCULAR RISK FACTORS AND MAY HELP PREDICT ADVERSE PROCEDURAL OUTCOMES. 256 PATIENTS WERE ANALYZED RETROSPECTIVELY WITH SEVERE CAC UNDERGOING RA. PATIENTS WERE DIVIDED INTO A SLOW FLOW GROUP (THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 0 TO 2) AND NORMAL FLOW GROUP (TIMI 3) BASED ON POST-RA ANGIOGRAPHIC ASSESSMENT. CLINICAL, PROCEDURAL, AND ANGIOGRAPHIC DATA WERE COMPARED. INDEPENDENT PREDICTORS WERE IDENTIFIED USING MULTIVARIATE LOGISTIC REGRESSION, AND RECEIVER OPERATING CHARACTERISTIC ANALYSIS ASSESSED THE PREDICTIVE PERFORMANCE OF VARIABLES. SLOW FLOW OCCURRED IN 18.8% OF PATIENTS. THE SLOW FLOW GROUP HAD SIGNIFICANTLY HIGHER CHA2DS2 VASC HSF SCORES, LONGER LESION LENGTHS, SMALLER REFERENCE VESSEL DIAMETERS, AND LOWER PREPROCEDURAL SYSTOLIC BLOOD PRESSURE (SBP). MULTIVARIATE ANALYSIS IDENTIFIED ALL FOUR AS INDEPENDENT PREDICTORS. THE CHA2DS2 VASC HSF SCORE ALONE HAD MODERATE PREDICTIVE VALUE (AREA UNDER THE CURVE AUC IS 0.658), WHILE A COMBINED MODEL INCORPORATING THE SCORE WITH LESION LENGTH, REFERENCE DIAMETER, AND SBP ACHIEVED THE HIGHEST ACCURACY AUC IS 0.893. SLOW FLOW WAS ALSO ASSOCIATED WITH A HIGHER IN-HOSPITAL RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS. THERE WERE 2 IN-HOSPITAL ALL-CAUSE MORTALITY. THE CHA2DS2 VASC HSF SCORE IS AN INDEPENDENT PREDICTOR OF SLOW FLOW DURING RA AND, WHEN COMBINED WITH ANATOMICAL AND HEMODYNAMIC VARIABLES, MAY ENHANCE RISK STRATIFICATION. THESE FINDINGS SUPPORT ITS USE IN PREPROCEDURAL PLANNING FOR PATIENTS WITH SEVERE CAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622268 ROTAWIRE? DRIVE AND WIRECLIP? TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION H74939463001 08714729996231

    Patients

    Seq Age Sex Outcome Treatment
    1