BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-FLO 4F SL 55CM MST-70 KIT, VALVED WITH NITINOL GUIDEWIRE PG

    MDR report key: 25323442 · Received May 28, 2026

    Report

    Report Number
    3030714660-2026-00009
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458910
    PMA / PMN Number
    K150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE INTRODUCER SPLITTING COULD NOT BE CONFIRMED FROM A VISUAL INSPECTION AS THE DEVICE WAS DISPOSED OF BEFORE A PICTURE COULD BE PROVIDED. A DHR REVIEW OF THE PACKAGING/ASSEMBLY/VALVE LOTS WAS CONDUCTED FOR ANY DEVIATIONS RELATED TO THE REPORTED INTRODUCER SPLITTING FAILURE MODE. THE REVIEW CONFIRMED THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS WITH NO INTERNAL NON-CONFORMANCE REPORTS (NCR) WRITTEN. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTABLE TO USE-RELATED FACTORS, SPECIFICALLY END-USER TECHNIQUE RESULTING IN INTRODUCER SPLIT. THE EVENT REMAINS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH CATHETER PLACEMENT, AND DOES NOT INDICATE A NEW HAZARD OR HAZARDOUS SITUATION. LABELING REVIEW WAS PERFORMED. THE DFU ADDRESSES THE REPORTED FAILURE MODE AND PROVIDES APPROPRIATE GUIDANCE. THE DFU THAT IS SUPPLIED WITH THE PRODUCT (16600224-01) CONTAINS THE FOLLOWING DIRECTIONS AND PRECAUTIONS: IF CATHETER OR ACCESSORIES SHOW SIGNS OF DAMAGE, DO NOT USE NOTE: ENSURE SHEATH LIES WITHIN VESSEL. D. RETRACT NEEDLE HALFWAY OUT OF PEELABLE SHEATH, MAINTAINING SHEATH POSITION. E. HOLD PEELABLE SHEATH IN PLACE AND REMOVE SAFETY NEEDLE PER MANUFACTURER'S INSTRUCTIONS FOR USE. DISCARD ACCORDING TO INSTITUTIONAL PROTOCOL. NOTE: DO NOT REINSERT INTRODUCER NEEDLE INTO PEELABLE SHEATH, AS THIS MAY CAUSE DAMAGE TO SHEATH. CATHETER PLACEMENT USING GUIDEWIRE: C. SELDINGER TECHNIQUE: WITHDRAW THE DILATOR, LEAVING THE SHEATH AND GUIDEWIRE IN PLACE. MODIFIED TECHNIQUE: WITHDRAW DILATOR AND GUIDEWIRE, LEAVING PEELABLE SHEATH IN PLACE. COVER OPENING TO PREVENT BLOOD LOSS AND/OR AIR EMBOLISM. 14. SLOWLY AND INCREMENTALLY, INSERT CATHETER THROUGH THE PEELABLE SHEATH TO DESIRED TIP POSITION. NOTE: IF PRACTICING SELDINGER TECHNIQUE, WET THE EXPOSED SEGMENT OF THE 145 CM GUIDEWIRE WITH SALINE AND THREAD CATHETER OVER GUIDEWIRE FIRST. 15. HOLDING CATHETER STEADY, SLOWLY WITHDRAW PEELABLE SHEATH FROM INSERTION SITE. 16. GRASP WINGS OF SHEATH FIRMLY AND PULL APART APPLYING EQUAL PRESSURE TO BOTH WINGS - PEEL THE SHEATH AWAY FROM THE CATHETER USING A FORWARD MOTION. A TREND ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY WITH NO ADVERSE TRENDS NOTED. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR ANY ADVERSE TRENDS. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A NEW ZEALAND DISTRIBUTOR REPORTED AN ISSUE WHEN USING THE BIO-FLO 4F SL 55 CM MST-70 KIT, VALVED WITH NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT AN INTRODUCER/DILATOR SPLIT DURING PLACEMENT. THE DEVICE WAS PLACED SUCCESSFULLY AFTER AN ALTERNATE INTRODUCER/DILATER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR HARM WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454893 BIO-FLO 4F SL 55CM MST-70 KIT, VALVED WITH NITINOL GUIDEWIRE PG PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5844829 H965458910

    Patients

    Seq Age Sex Outcome Treatment
    1