BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY PRO CORONARY SINUS GUIDE CATHETER MULTIPURPOSE SHEATH

    MDR report key: 17534514 · Received August 12, 2023

    Report

    Report Number
    MW5141415
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    March 24, 2022
    Report Date
    April 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS INJECTING CONTRAST INTO THE CORONARY SINUS TO VISUALIZE IF THERE WERE ANY BLOCKAGES, A SMALL DISSECTION OCCURRED. THE CALLER STATED THAT NO BIOSENSE WEBSTER, INC. PRODUCTS WERE IN THE BODY AT THIS POINT AND THAT THE PHYSICIAN WAS USING A BOSTON SCIENTIFIC ACUITY PRO CORONARY SINUS GUIDE CATHETER MULTIPURPOSE SHEATH. THE DISSECTION WAS CONFIRMED VIA FLUOROSCOPY AND NO INTERVENTION WAS PERFORMED. THE PHYSICIAN BELIEVES THAT THE "DISSECTION IS SMALL AND INSIGNIFICANT AND SHOULD HEAL ON ITS OWN". THE CALLER STATED THAT THE PATIENT IS "FINE" AT THIS MOMENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216758 ACUITY PRO CORONARY SINUS GUIDE CATHETER MULTIPURPOSE SHEATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown