BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL

    MDR report key: 4092372 · Received September 4, 2014

    Report

    Report Number
    3004672932-2014-00011
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K100819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    EVENT DETAILS AS REPORTED: "I'VE BEEN INFORMED TODAY THAT ONE OF OUR CUSTOMER (B)(6) HAD A CRITICAL ISSUE YESTERDAY WITH SOLOPATH DURING TAVI PROCEDURE. IT WAS APPARENTLY WITH A STFI-2135 (OLD VERSION) USED WITH AN EDWARDS SAPIEN 26MM (TO BE CONFIRMED AS SOON AS I'LL HAVE INFORMATION FROM THE CATHLAB). THE ARTERY WAS AROUND 5 MM AND SEVERELY CALCIFIED WITH A STENT IN ILIAC SEGMENT. INSERTION OF THE SOLOPATH AND VALVE IMPLANTATION UNDERGONE WITHOUT ANY PROBLEM, BUT WHEN THE PHYSICIAN WANTED TO PULL BACK THE SOLOPATH, IT STAYED TUCKED INTO THE ARTERY. SO HE TRIED TO PULL HARDER AND FINALLY RIPPED THE SHEATH IN 2 PARTS. ONE OUTSIDE OF THE PATIENT AND THE OTHER STAYED INTO THE ARTERY. FOR THE MOMENT, THE PATIENT STATUS IS STABLE AND THE PHYSICIAN DOESN'T KNOW YET IF HE WILL REMOVE THE REMAINING PART FROM THE ARTERY BECAUSE OF THE BAD GENERAL STATUS OF THE PATIENT..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541500 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER DYB ONSET MEDICAL CORPORATION STFI-2135 W034878

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Other EDWARDS SAPIEN 26 MM| EDWARDS SAPIEN 26 MM