BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    MDR report key: 776254 · Received November 2, 2006

    Report

    Report Number
    2182269-2006-00234
    Event Type
    Other
    Date Received
    November 2, 2006
    Date of Event
    October 5, 2006
    Report Date
    November 2, 2006
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO 8F FAST-CATH INTRODUCERS AND DILATORS WERE RECEIVED FOR EVALUATION. THE INTRODUCERS WERE LABELED A AND B FOR EVALUATION PURPOSES. THE INNER DIAMETER OF THE SHEATH WITHIN THE HUB AND AT THE SHEATH TIP WERE CONFIRMED TO BE WITHIN ST. JUDE MEDICAL SPECIFICATIONS. DILATORS A AND B WERE SUCCESSFULLY ADVANCED THROUGH BOTH INTRODUCERS WITHOUT ABNORMAL RESISTANCE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. IN CONCLUSION, VISUAL, FUNCTIONAL AND DIMENSIONAL TESTING REVEALED NO ANOMALIES WITH THE RETURNED INTRODUCERS OR DILATORS. THE CATHETER USED IN CONJUNCTION WITH THESE INTRODUCERS WAS NOT RETURNED AND MAY HAVE AIDED IN A MORE THOROUGH INVESTIGATION OF THE REPORTED EVENT. THE BIOSENSE WEBSTER INSTRUCTIONS FOR USE INSTRUCT THE USER TO ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION TO VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED RESISTANCE WAS NOTED WHEN PASSING THE 7.5F BIOSENSE NAVISTAR CATHETER THROUGH THE 8F INTRODUCER; PARTICULARYLY WHEN THE DISTAL PORTION WAS PASSED THROUGH THE INTRODUCER. WHILE ATTEMPTING TO PULL THE CATHETER BACK, IT WOULD NOT PASS THROUGH THE SHEATH. THE CATHETER AND INTRODUCER HAD TO BE REMOVED TOGETHER. THE TRANSSEPTAL PUNCTURE HAD TO BE COMPLETED AGAIN AND PROCEDURE TIME WAS EXTENDED. THIS OCCURRED WITH TWO INTRODUCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F SWARTZ TRANSSEPTAL SL1 DYB ST. JUDE MEDICAL NA 1227738

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other