BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 8849154 · Received July 31, 2019

    Report

    Report Number
    2029046-2019-03472
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DYB
    UDI-DI
    10846835000047
    PMA / PMN Number
    K982740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/16/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THE DEVICE WAS RETURNED IN AN OPEN PACKAGE WITH SOME TYPE LIQUID MATERIAL ON BRIM CAP AND HEMOSTATIC VALVE ALONG WITH A FEW FOREIGN FIBERS OF BLACK COLOR. THE FINDINGS HAVE BEEN REVIEWED AND THE FINDINGS REMAIN MDR REPORTABLE FOR THE FOREIGN MATERIAL. MANUFACTURER'S REF#: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WHEREIN A FOREIGN MATERIAL ISSUE OCCURRED. IT WAS REPORTED THAT UPON OPENING THE PRODUCT, DISTRIBUTOR NOTICED THAT THE PACKAGING AND VALVE SURFACE OF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE APPEARED CONTAINED AN OILY-LOOKING SOLUTION. THERE WERE NO REPORTS OF PATIENT CONSEQUENCE. ON 9/16/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THE DEVICE WAS RETURNED IN AN OPEN PACKAGE WITH SOME TYPE LIQUID MATERIAL ON BRIM CAP AND HEMOSTATIC VALVE ALONG WITH A FEW FOREIGN FIBERS OF BLACK COLOR. THE FINDINGS HAVE BEEN REVIEWED AND THE FINDINGS REMAIN MDR REPORTABLE FOR THE FOREIGN MATERIAL. DEVICE EVALUATION DETAILS: THE DEVICE WAS INSPECTED AND PACKAGE WAS FOUND OPEN; NOT CLOSED. LIQUID MATERIAL WAS FOUND ON BRIM CAP AND HEMOSTATIC VALVE ALONG WITH BLACK FOREIGN FIBERS. DURING THE SECOND VISUAL INSPECTION, IT WAS FOUND THAT THE GASKET OF THE CANNULA WAS COVERED WITHIN A TUBE AND SEALED WITH ADHESIVE TAPE. THE GASKET OF THE CANNULA PRESENTS AN OILY SUBSTANCE. PER VISUAL ANALYSIS AND THE PRODUCTION ENGINEERING TEAM, THE OILY-LOOKING SOLUTION REPORTED BY THE CUSTOMER WAS DETERMINED TO BE MEDICAL FLUID; WHICH IS INHERENT TO THE MANUFACTURING PROCESS. THE MEDICAL FLUID IS INTENDED TO LUBRICATE THE INTERACTION BETWEEN THE VESSEL DILATOR AND THE GASKET COMPONENT. NEITHER THE PRODUCT HISTORY REVIEW (PHR) REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. A FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST (FTIR) WAS PERFORMED AND THE RESULTS SHOWED POLYETHYLENE COMPOSITION WITH MDX 1.5% COATING SOLUTION; SINCE CHARACTERISTIC INFRA RED (IR) BANDS FOUND ON SPECTRUM CORRESPONDING TO THESE MATERIALS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT REGARDING THE OILY-LOOKING SOLUTION CANNOT BE CONFIRMED, THIS IS PART OF THE DEVICE. MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    STILL PENDING IS THE MANUFACTURER RECORD EVALUATION, MANUFACTURED DATE AND THE EXPIRATION DATE. THEREFORE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WHEREIN A FOREIGN MATERIAL ISSUE OCCURRED. IT WAS REPORTED THAT UPON OPENING THE PRODUCT, DISTRIBUTOR NOTICED THAT THE PACKAGING AND VALVE SURFACE OF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE APPEARED CONTAINED AN OILY-LOOKING SOLUTION. THERE WERE NO REPORTS OF PATIENT CONSEQUENCE. THE ISSUE OF FOREIGN MATERIAL HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638436 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC. 17763026 10846835000047

    Patients

    Seq Age Sex Outcome Treatment
    1