BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGAGE INTRODUCER, TF 5 FR 12 CM 0.038 GW

    MDR report key: 1910529 · Received November 19, 2010

    Report

    Report Number
    2182269-2010-00216
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ST. JDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K092575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; HOWEVER ELEVEN PHOTOS WERE OBTAINED OF THE USED PRODUCT. ELEVEN IMAGES WERE VISUALLY INSPECTED; NO DEVICE COMPONENTS WERE RETURNED. THE IMAGES SHOW AN OBJECT CONSISTENT IN APPEARANCE WITH A 5F ENGAGE HEMOSTASIS SHEATH. BASED SOLELY UPON THE AFOREMENTIONED IMAGES, IT APPEARED THAT THE SHEATH TUBING HAD BEEN SEVERED APPROXIMATELY 0.4" DISTAL TO THE STRAIN RELIEF. STRETCHED AND TORN MATERIAL WAS VISIBLE ON THE DISTAL END OF THE ATTACHED TUBING SEGMENT AND ON ONE END OF THE DETACHED TUBING SEGMENT; THE DAMAGE INDICATED FORCIBLE DETACHMENT. NO ADDITIONAL EVALUATION WAS POSSIBLE. 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 ENGAGE HEMOSTASIS INTRODUCER SHEATH INSTRUCTION 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 ENGAGE INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES INDIVIDUAL PATIENT ANATOMY AND PHYSICIAN TECHNIQUE MAY REQUIRE PROCEDURAL VARIATIONS. THE ENGAGE INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT THE USER SHOULD NOT ATTEMPT TO INSERT A CATHETER HAVING A DISTAL TIP OR BODY LARGER THAN THE INTRODUCER SIZE INDICTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A PERCUTANEOUS HEART CATHETERIZATION. THE 5F ENGAGE INTRODUCER SHEATH WAS LEFT INDWELLING AS THE PATIENT WAS MOVED TO THE HOLDING AREA. WHEN AN ATTEMPT WAS MADE TO REMOVE THE INTRODUCER, RESISTANCE WAS FELT AND ANOTHER ATTEMPT WAS MADE BY DECREASING THE ANGLE OF THE SHEATH TO SKIN SURFACE, THE RESISTANCE REMAINED. THE SHEATH "BROKE" ABOUT 1/2 INCH DOWN FROM THE BOTTOM OF THE HUB, LEAVING 10 CM LENGTH OF THE REMAINING TUBE PORTION OF THE SHEATH IN THE PATIENT. THE SHEATH WAS SURGICALLY REMOVED AND THE PATIENT WAS REPORTED TO BE FINE. THE PATIENT WAS REPORTED TO HAVE ARTERIAL CALCIFICATION. THE INTRODUCER WILL BE RETAINED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGAGE INTRODUCER, TF 5 FR 12 CM 0.038 GW ENGAGE INTRODUCER DYB ST. JDE MEDICAL NA 3079427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R