BEUDAMED
    FDA Adverse Event Death Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 1821932 · Received August 31, 2010

    Report

    Report Number
    2015691-2010-13974
    Event Type
    Death
    Date Received
    August 31, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "THIS MEDWATCH HAS BEEN SUBMITTED IN ERROR. ALTHOUGH A 510 K HAS BEEN OBTAINED, THE DEVICE IS NOT COMMERCIALLY AVAILABLE. THE DEVICE IS CURRENTLY BEING USED IN A CLINICAL TRIAL (B)(4) AND IS LABELED AS AN INVESTIGATIONAL DEVICE ONLY."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE OF AN ANTI-SIPHON PCA COMBINATION SET THAT HAS A CUT IN THE TUBING. THE CONDITION WAS OBSERVED DURING PRIMING. THE MEDICATION INVOLVED WAS DEMEROL. THE PACKAGING WAS NOT DAMAGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SHEATH TRACKED, AND TRANSCATHETER HEART VALVE DEPLOYED WITHOUT ISSUE. UPON SHEATH REMOVAL, THERE WAS A VASCULAR TEAR ON THE SIDE OF THE SHEATH TRACKING WHICH REQUIRED COVERED STENTS TO BE PLACED. WIRE FROM CONTRALETERAL LEG TRACKED THROUGH FALSE LUMEN AND REQUIRED SURGICAL REPAIR AT PERCUTANEOUS CLOSURE SITE. ON (B)(6) 2010 - PATIENT NOTED TO HAVE COMPARTMENT SYNDROME COMPLICATING THE PERFORATION. SHE HAD LAPARATOMY AND DETERIORATED AND PASSED AWAY. THE DEVICE RELATIONSHIP WAS REPORTED TO BE REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET CATHETER INTRODUCER DYB EDWARDS LIFESCIENCES 9120S23 58898637

    Patients

    Seq Age Sex Outcome Treatment
    1