BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSTAR

    MDR report key: 8614031 · Received May 15, 2019

    Report

    Report Number
    3006260740-2019-01394
    Event Type
    Death
    Date Received
    May 15, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A LOT HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED HEART PERFORATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE GUIDEWIRE. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE CLINICIAN ERROR AND DISTAL TIP TOO SHARP/STIFF; HOWEVER, THE LACK OF A RETURNED SAMPLE PREVENTED BOTH CONFIRMATION OF THE REPORTED EVENT AND IDENTIFICATION OF A ROOT CAUSE(S). LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CATHETER PLACEMENT THE GUIDEWIRE ALLEGEDLY PERFORATED THE HEART AND CARDIAC TAMPONADE OCCURRED REQUIRING INTERVENTION, WHICH RESULTED IN THE PATIENT EXPIRING.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATHETER PLACEMENT THE GUIDEWIRE ALLEGEDLY PERFORATED THE HEART AND CARDIAC TAMPONADE OCCURRED REQUIRING INTERVENTION, WHICH RESULTED IN THE PATIENT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404505 HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER MSD BARD ACCESS SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death