BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS

    MDR report key: 18852413 · Received March 6, 2024

    Report

    Report Number
    2124215-2024-13915
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    April 1, 2022
    Report Date
    March 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENGUTTUVAN NB, ET AL., ECMO ASSISTED CHIP PCI FOR A PATIENT WITH SINGLE SURVIVING VESSEL WITH MODERATE TO SEVERE CALCIFIED DISEASE WITH SEVERE BIVENTRICULAR DYSFUNCTION [ABSTRACT]. J AM COLL CARDIOL. 2022; 79 (15 SUPPLEMENT): S200-S3. ABSTRACT TCTAP C-073. 27TH CARDIOVASCULAR SUMMIT TRANSCATHETER CARDIOVASCULAR THERAPEUTICS ASIA PACIFIC (TCTAP) VIRTUAL, ONLINE 2022-04-27 TO 2022-04-29.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. THE 89-90% STENOSED, ECCENTRIC TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED OSTIO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. ONCE THE OPTICROSS CATHETER HAD CROSSED INTO THE LAD, THE PATIENT EXPERIENCED A SUDDEN FALL IN BLOOD PRESSURE. THE OPTICROSS CATHETER WAS REMOVED, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. FOLLOWING THIS, THE LAD WAS PRE DILATED USING A NON-BOSTON SCIENTIFIC BALLOON, AND THE OPTICROSS CATHETER WAS ADVANCED AGAIN. UPON ADVANCING AGAIN, THE PATIENT DEVELOPED BRADYCARDIA AND HYPOTENSION. A QUICK MANUAL PULLBACK WAS DONE, AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES RESULTING IN TIMI 3 FLOW, AND THE ECMO WAS DECANNULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175388 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention