BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TF SHEATH UNKNOWN

    MDR report key: 17347571 · Received July 18, 2023

    Report

    Report Number
    2015691-2023-14672
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 31, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, A REDACTION TO THIS REPORT IS REQUIRED. THERE WAS NEW INFORMATION RECEIVED FROM THE SITE CLARIFYING THAT THE SITE MEANT LINER TORN AND NOT DISTAL TIP SPLIT. THE ROOT CAUSE OF THE EVENT REMAINS UNKNOWN. LINER TEARING TYPICALLY RESULTS FROM CONTACT WITH CALCIFIED VESSELS DURING THE TVR PROCEDURE, AND CAN PROPAGATE DURING DEVICE MANIPULATIONS THROUGH THE SHEATH, AND/OR DURING WITHDRAWAL OF THE SHEATH FROM THE PATIENT. THIS MAY RESULT IN BLOOD LEAKAGE AS THE SHEATH IS WITHDRAWN FROM THE PATIENT; HOWEVER, SHEATHS ARE TYPICALLY REMOVED EXPEDITIOUSLY, AND THE AMOUNT OF BLOOD LOSS IS UNLIKELY TO RESULT IN SERIOUS INJURY. QUANTIFICATION OF INTRAPROCEDURAL BLOOD LOSS IS INEXACT. BLOOD TRANSFUSIONS MAY BE GIVEN FOR VARIOUS REASONS, INCLUDING PRE-EXISTING ANEMIA AND MULTIPLE VASCULAR PUNCTURES. IF THE LINER IS TORN, AND A BLOOD TRANSFUSION IS NOT REQUIRED, THE EVENT IS NOT REPORTABLE. WITH THE NEW INFORMATION PROVIDED, THIS EVENT IS NO LONGER REPORTABLE TO THE FDA. AS THE NEW INFORMATION INDICATES, THERE WAS NO BLOOD TRANSFUSION REQUIRED, THEREFORE A SERIOUS INJURY DID NOT OCCUR, AND NO SURGICAL/ADDITIONAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. IN THIS CASE, THE EXACT SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TRANSFEMORAL SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TRANSFEMORAL SHEATH: K200258 - EDWARDS EXPANDABLE INTRODUCER SHEATH SET; K200258 - EDWARDS ESHEATH INTRODUCER SET. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    PER REPORT RECEIVED FROM THE UNITED KINGDOM, IT WAS A CASE OF A VALVE IMPLANT WHEN IT WAS FOUND THAT AN ESHEATH HAD SPLIT. FURTHER INFORMATION HAS NOT BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837223 TF SHEATH UNKNOWN INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown