BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    MDR report key: 10040823 · Received May 8, 2020

    Report

    Report Number
    9710452-2020-00015
    Event Type
    Injury
    Date Received
    May 8, 2020
    Report Date
    May 8, 2020
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K102948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. THERE IS NO SUSPECTED DEVICE FAILURE.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, A BAYLIS MEDICAL DEVICE WAS IDENTIFIED AMONG SEVERAL OTHER MANUFACTURER'S DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS A BAYLIS DEVICE WAS AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: DELLA ROCCA, D.G., HORTON, R.P, DI BIASE, L., BASSIOUNY, M., AL-AHMAD, A., MOHANTY, S., GASPERETTI, A., NATALE, V.N., TRIVEDI, C., GIANNI, C., BURKHARDT, J.D., GALLINGHOUSE, G.J., HRANITZKY, P., SANCHEZ, J.E. NATALE, A. (2020) FIRST EXPERIENCE OF TRANSCATHETER LEAK OCCLUSION WITH DETACHABLE COILS FOLLOWING LEFT ATRIAL APPENDAGE CLOSURE. JACC: CARDIOVASC. INTERVENT; 13(3): 306-319. DOI: HTTPS://DOI.ORG/10.1016/J.JCIN.2019.10.022. AS PER THIS ARTICLE: THERE WAS ONE MAJOR ADVERSE DEVICE-RELATED EVENT IN AN (B)(6) MAN (PATIENT #(B)(6)), WHO DEVELOPED PERICARDIAL TAMPONADE REQUIRING A PERICARDIAL WINDOW. THE PATIENT WAS DISCHARGED HOME ON THE THIRD DAY POST-ADMISSION. A (B)(6) WOMAN (PATIENT #(B)(6)) DEVELOPED A SMALL PERICARDIAL EFFUSION WITHOUT HEMODYNAMIC COMPROMISE. SUBSEQUENT SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED, AND 160 ML OF SEROSANGUINOUS FLUID WAS ASPIRATED FROM THE PERICARDIAL SPACE. THE PATIENT WAS DISCHARGED HOME ON THE FOLLOWING DAY WITH A STABLE LEVEL OF HEMOGLOBIN AND NO FURTHER EVIDENCE OF PERICARDIAL EFFUSION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501496 TORFLEX TRANSSEPTAL GUIDING SHEATH CATHETER INTRODUCER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention