BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F

    MDR report key: 10935980 · Received December 2, 2020

    Report

    Report Number
    3005334138-2020-00591
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    February 4, 2021
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    DYB
    UDI-DI
    05414734204088
    PMA / PMN Number
    K894431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE 6F PEEL AWAY INTRODUCER SHEATH AND DILATOR WERE RECEIVED FOR EVALUATION. NO ANOMALIES, INCLUDING THE REPORTED BEND, WERE NOTED ON THE RETURNED DILATOR. THE SHEATH TUBING HAD BEEN FULLY PEELED ALONG THE INTENDED SCORELINES. FUNCTIONAL TESTING WAS NOT POSSIBLE DUE TO THE RETURNED CONDITION OF THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE RECEIVED CONDITION OF THE DEVICE AND THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED INSERTION DIFFICULTY AND BEND REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING A DEVICE REPLACEMENT AND RV LEAD PLACEMENT PROCEDURE, THE CASE WAS CANCELLED. THE TIP OF THE SHEATH WAS BENT WHEN INSERTING INTO THE RIGHT SUBCLAVIAN VEIN, AND IT COULD NOT BE INSERTED. THE INTRODUCER WAS REPLACED AND PEELED, BUT THE LEAD COULD NOT ADVANCE TO THE TARGET POSITION. THE REPLACEMENT INTRODUCER ALSO BECAME BENT DURING USE. THE PROCEDURE WAS RESCHEDULED, AND THE SHEATH WOULD BE INSERTED VIA THE LEFT SUBCLAVIAN VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401450 PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL (AFD-PLYMOUTH) 405104 7213811 05414734204088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other