BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFACER®

    MDR report key: 25036414 · Received April 29, 2026

    Report

    Report Number
    1721504-2026-00012
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    QJH
    UDI-DI
    00884450419809
    PMA / PMN Number
    DEN190038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROVIDER WAS PLANNING TO USE THE SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM TO OBTAIN CENTRAL VENOUS ACCESS DUE TO KNOWN CENTRAL VENOUS STENOSIS, FOLLOWED BY CONVERSION TO HERO GRAFT PLACEMENT DURING THE SAME PROCEDURE. REVIEW OF PRE-PROCEDURAL COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING DEMONSTRATED A TYPE II-III CENTRAL VENOUS OCCLUSION ABOVE THE AZYGOS VEIN. THE PHYSICIAN ALSO NOTED A KNOWN MILD INFERIOR VENA CAVA STRICTURE BUT DID NOT ANTICIPATE SIGNIFICANT DIFFICULTY WITH DEVICE ADVANCEMENT. DURING THE PROCEDURE, THE PATIENT WAS POSITIONED SUPINE AND FEMORAL VENOUS ACCESS WAS OBTAINED. DIAGNOSTIC IMAGING CONFIRMED OCCLUSION AT THE CONFLUENCE OF THE INTERNAL JUGULAR AND SUBCLAVIAN VEINS. A 12F × 45 CM DRYSEAL SHEATH WAS PLACED, AND THE SURFACER SHEATH WAS ADVANCED THROUGH THE PELVIC VASCULATURE TO THE LEVEL OF THE OCCLUSION WITH MINIMAL RESISTANCE. UPON ADVANCEMENT OF THE SURFACER CATHETER THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED IN THE ILIAC REGION. MULTIPLE ADVANCEMENT ATTEMPTS WERE MADE. FLUOROSCOPIC LATERAL IMAGING DEMONSTRATED ACUTE ILIAC VESSEL TORTUOSITY CORRESPONDING TO THE AREA OF RESISTANCE. PATIENT REPOSITIONING AND ALTERNATIVE IMAGING VIEWS DID NOT RESOLVE THE RESISTANCE. THE SHEATH WAS WITHDRAWN AND WAS OBSERVED BY THE PHYSICIAN TO HAVE SUPERFICIAL MID-SEGMENT SHEARING. TO IMPROVE SUPPORT, A 16F DRYSEAL SHEATH WAS PLACED, THROUGH WHICH A 12F DRYSEAL SHEATH AND THE SAME SHEATH WERE ADVANCED. DESPITE THESE MEASURES, FLUOROSCOPY CONTINUED TO DEMONSTRATE SIGNIFICANT VESSEL ANGULATION, AND RESISTANCE PERSISTED DURING CATHETER ADVANCEMENT. DURING SUBSEQUENT ADVANCEMENT ATTEMPTS, INCREASED FORCE WAS APPLIED. FLUOROSCOPIC IMAGING THEN DEMONSTRATED SEPARATION OF THE DISTAL TIP OF THE SURFACER CATHETER. THE CATHETER SHAFT WAS REMOVED INTACT, AND THE SEPARATED DISTAL TIP REMAINED CONTAINED WITHIN THE SHEATH. THE SHEATH WAS WITHDRAWN, AND THE DETACHED TIP WAS FLUSHED FROM THE SHEATH ONTO THE BACK TABLE. VISUAL INSPECTION INDICATED THE SEPARATION OCCURRED AT THE PROXIMAL EDGE OF THE DISTAL EYELET. NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THE PHYSICIAN ELECTED NOT TO USE AN ADDITIONAL SURFACER DEVICE AND INSTEAD OBTAINED VENOUS ACCESS VIA SHARP NEEDLE RECANALIZATION FROM THE INTERNAL JUGULAR VEIN, FOLLOWED BY SNARING AND SUCCESSFUL COMPLETION OF THE HERO GRAFT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266820 SURFACER® CENTRAL VENOUS CATHETER INSIDE-OUT INTRODUCTION SET QJH MERIT MEDICAL SYSTEMS, INC. H3410062 00884450419809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown