BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE

    MDR report key: 8962630 · Received September 4, 2019

    Report

    Report Number
    3005334138-2019-00485
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DETACHMENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS IN AN ARTICLE TITLED ¿RETRIEVAL OF A DETACHED TRANSSEPTAL SHEATH TIP FROM A RIGHT PULMONARY ARTERY BRANCH FOLLOWING CATHETER ABLATION" BY SCHRICKER ET AL. 2015. 86:1131.  ¿DURING REMOVAL OF THE REMAINING SL1, THE TERMINAL 2-CM TIP OF THE SHEATH BROKE OFF WITHIN THE RIGHT FEMORAL VEIN AS THE SHEATH WAS BEING REMOVED FROM THE VEIN. THERE WAS NO EXCESSIVE FORCE OR PULLING OF THE SHEATH DURING REMOVAL, ALTHOUGH THERE WAS SOME RESISTANCE TO ITS REMOVAL INITIALLY. FLUOROSCOPY DEMONSTRATED THAT THE RADIOPAQUE TIP HAD EMBOLIZED AND WAS OSCILLATING IN THE UPPER RIGHT ATRIUM NEAR THE RIGHT ATRIAL¿SUPERIOR VENA CAVA JUNCTION. SHEATH TIP RETRIEVAL TOOK 90 MINUTES, WHICH INCLUDED 60 MIN OF FLUOROSCOPY. THE PATIENT EXPERIENCED NO IMMEDIATE COMPLICATIONS, AND 15 MONTHS POSTPROCEDURE HE REMAINS FREE OF BOTH PROCEDURAL RELATED COMPLICATIONS AND ARRHYTHMIA.¿ (DOI: 10.1002/CCD.25957) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756498 FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 406840

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R