BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 4221614 · Received November 3, 2014

    Report

    Report Number
    9673241-2014-00463
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DYB
    PMA / PMN Number
    K982740
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A PREFACE GUIDING SHEATH WITH MULTIPURPOSE CURVE AND AN OCCLUSION OCCURRED PREVENTING TO FLUSH IT. DURING PROCEDURE, THE PUMP (NON BWI PRODUCT) DISPLAYED AN OCCLUSION WARNING. WHEN THE THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER WAS INSERTED, IT OCCLUDED THE SHEATH LUMEN PREVENTING TO FLUSH. THIS OCCURRED INSIDE THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED BY EXCHANGING CATHETER AND SHEATH. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON RECEIPT, THE PREFACE SHEATH (SHEATH INTRODUCER) WAS VISUALLY INSPECTED AND SOME BUMPS WERE OBSERVED BETWEEN THE SIDE¿S HOLES. THIS CONDITION WAS NOT REPORTED AND OBSERVED BY THE CUSTOMER. VESSEL DILATOR WAS ALSO RETURNED AND IT WAS FOUND IN GOOD CONDITIONS AS WELL. THEN PER THE REPORTED EVENT, A MICROSCOPIC VISUAL INSPECTION WAS PERFORMED OVER THE TWO DEVICES AND NO DAMAGES WERE OBSERVED BESIDES THE BUMPS. AFTERWARDS, A DIMENSIONAL TESTING WAS PERFORMED OVER THE VESSEL DILATOR AND SHEATH INTRODUCER AND BOTH WERE WITHIN SPECIFICATIONS. IN ADDITION, THE VESSEL DILATOR WAS INTRODUCED THROUGH THE SHEATH INTRODUCER AND NO RESISTANCE/FRICTION WAS EXPERIENCED. FINALLY A LAB SAMPLE SMART TOUCH WAS INTRODUCED THROUGH THE SHEATH INTRODUCER, AN IRRIGATION TEST WAS THEN PERFORMED AND NO OCCLUSIONS WERE OBSERVED. WATER WAS FLOWING NORMALLY. 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 WAS NOT CONFIRMED. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS RESULTS USING MONTHLY COMPLAINT TREND REPORTING. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. CONCOMITANT BWI PRODUCTS: PRODUCT: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER, US CATALOG # D133601, LOT # 17024440M, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND AN OCCLUSION OCCURRED PREVENTING TO FLUSH IT. DURING PROCEDURE, THE PUMP (NON BWI PRODUCT) DISPLAYED AN OCCLUSION WARNING. WHEN THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS INSERTED, IT OCCLUDED THE SHEATH LUMEN PREVENTING TO FLUSH. THIS OCCURRED INSIDE THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED BY EXCHANGING CATHETER AND SHEATH. THIS COMPLAINT IS BEING REPORTED DUE TO THE POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702798 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER, INC. (JUAREZ) 301803M OEM_301803M

    Patients

    Seq Age Sex Outcome Treatment
    1