BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 6193371 · Received December 21, 2016

    Report

    Report Number
    2126666-2016-00101
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    October 5, 2016
    Report Date
    January 18, 2017
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. REVIEW OF THE DFU NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. THE PRODUCT IS EXPECTED TO BE RETURNED; IF ADDITIONAL INFORMATION IS RECEIVED OR PRODUCT IS RETURNED A FOLLOW-UP MEDWATCH WILL BE FILED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE SAFARI2 GUIDEWIRE WAS RETURNED FOR ANALYSIS ON 01/06/2017. IT WAS INITIALLY REPORTED THAT THE COMPLAINT WAS RELATED TO A SAFARI GUIDEWIRE; HOWEVER, THE ACTUAL DEVICE RETURNED WAS DIMENSIONALLY CONSISTENT WIRH A SAFARI2 275CM SML CRV GUIDEWIRE. AS RECEIVED, THE SPECIMEN CONSISTED OF ONE EACH CLINICALLY USED, DAMAGED UNIDENTIFIED SAFARI WIRE; RETURNED COILED, LOOSE AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCHES. THE SPECIMEN PRESENTED A LARGE RADIUS BEND LOCATED 17.5 TO 31.0CM FROM THE DISTAL ASPECT OF THE PREFORMED CURVE AND A KINK LOCATED 186.1 TO 186.2CM FROM THE DISTAL ASPECT OF THE PREFORMED CURVE. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN. BOTH JOINTS WERE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NON-DESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARED VISUALLY AND DIMENSIONALLY CONSISTENT WITH A SAFARI2 275CM SML CRV DEVICE. THERE WAS NO MENTION OF THE BEND AND KINK IN THE INTIAL COMPLAINT SO IT COULD NOT BE CONFIRMED IF THE DAMAGE OCCURRED DURING THE PROCEDURE OR DURING HANDLING AND SHIPPING POST PROCEDURE. THE BATCH NUMBER WAS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. REVIEW OF THE DFU NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE AND THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, CLINICAL AND/OR PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE EVENT AS REPORTED.

    Description of Event or Problem · 1

    AS REPORTED: "THE CIRCULATION OF THE PATIENT WAS DURING THE WHOLE PROCEDURE INSTABLE (40/20MMHG BLOOD PRESSURE AND TEMPORARY ASYSTOLE). AFTER THE FIRST POSITIONING THERE WAS A PVL, SO THEY DECIDED TO REPOSITION THE VALVE. DURING RESEATING THE PATIENT BECAME ASYSTOLIC. DURING THE RESUSCITATION THE REPOSITIONING WAS NOT POSSIBLE. AFTER CA. 45 MINUTES THEY DECIDED TO FINISH THE RESUSCITATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843484 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death