BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-CATH HEMOSTASIS INTRODUCER 6F, 12CM SHEATH

    MDR report key: 1082285 · Received July 25, 2008

    Report

    Report Number
    2182269-2008-00185
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K870374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES THAT THE USER SHOULD ADVANCE THE DILATOR/SHEATH ASSEMBLY WITH A TWISTING MOTION TO AVOID DAMAGE TO THE SHEATH OR VESSEL. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES INDIVIDUAL PATIENT ANATOMY AND PHYSICIAN TECHNIQUE MAY REQUIRE PROCEDURAL VARIATIONS. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO INSERT THE DILATOR INTO HEMOSTASIS VALVE AND THEN FOLLOW NORMAL ACCEPTED PRACTICE FOR VESSEL PUNCTURE, GUIDEWIRE INSERTION, VESSEL DILATOR AND HEMOSTASIS INTRODUCER USE. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES THAT PRIOR TO PROCEEDING, VERIFY THE HEMOSTASIS INTRODUCER IS OF PROPER SIZE TO ALLOW PASSAGE OF DESIRED CATHETER OR OTHER MEDICAL DEVICE. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES THAT THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS THOROUGHLY TRAINED IN THE TECHNIQUE OF ANGIOGRAPHY AND/OR THE USE OF CATHETER DELIVERY SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS PROCEDURE IN THE CARDIAC CATH LAB STRONG RESISTANCE WAS EXPERIENCED WHEN INSERTING THE GUIDEWIRE INTO A 6F FAST CATH INTRODUCER SHEATH. REPORTEDLY, THE GUIDEWIRE PERFORATED THE SHEATH WALL AND THE VESSEL. MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMOSTASIS INTRODUCER 6F, 12CM SHEATH FAST-CATH 6F, 12CM DYB ST. JUDE MEDICAL NA 2071916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other