BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTASIS VALVE/SHEATH ASSEMBLY

    MDR report key: 48515 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00083
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 23, 1996
    Report Date
    August 29, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738, 1701. THE IAB WITH SERIAL NUMBER R1514340 WAS RETURNED FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. IN ADDITIONO, A CLEAR, 10 FRENCH, 6 INCH HEMOSTASIS VALVE ASSEMBLY WAS ALSO RETURNED, BUT IT WAS SEPARATED FROM THE IAB CATHETER (SAME AS THE ONE USED IN 2242850 -1996-00082). KINKS WERE NOTED IN THE SHEATH. VISUAL EXAMINATION REVEALED THAT THE RETURNED BLUE DIALATOR WAS PRESENT THROUGH THE HEMOSTASIS VALVE. BLOOD WAS NOTED ON THE EXTERIOR OF THE SHEATH/ CLEAR HEMOSTASIS VALVE ASSEMBLY.THE I.D. OF THE SHEATH AND THE O.D. OF THE CATHETER WERE MEASURED AND FOUND TO BE WITHIN CO'S MANUFACTURING SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO CO'S MANUFACTURING SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING LABORATORY IAB, THE SHEATH/ HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STA-GARD. AGAIN, THE ASSEMBLY PASSED THIS LEAK TEST. WHEN THE HEMOSTASIS VALVE ASSEMBLY WAS TESTED WITH JUST A LABORATORY GUIDEWIRE IN PLACE THROUGH THE VALVE ASSEMBLY, LEAKAGE DID OCCUR. A 60CC. VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY.PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED IAB AND SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTIES DURING LABORATORY EXAMINATION. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH/HEMOSTASIS VALVE ASSEMBLY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: -THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. -IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. -DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. -THE PT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. -DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH. -THE CATHETER AND/OR INNER LUMEN KINKED SURING INSERTION IF THE BALLOON WAS NOT SUPPORTED BY A GUIDE WIRE. -THE CATHETER WASHELD TOO FAR BACK FROM THE SITE OF INSERTION.SINCE NO ADDITIONAL INFORMATION WAS PROVIDED WITH THE DEIVCE WAS RETURNED TO CO FOR EXAMINATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE REPORTED VALVE LEAK. AGAIN, LABORATORY EXAMINATION OF THE VALVE REVEALED NO LEAKS WHEN THE CATHETER WAS PRESENT, BUT EXAMINATION OF THE VALVE WITH JUST THE GUIDEWIRE PRESENT DID REVEAL A LEAK.

    Description of Event or Problem · 1

    THE DOCTOR HAD DIFFICULTY INSERTING THE IAB INTO THE HEMOSTASIS VALVE. THE HEMOSTASIS VALVE LEAKED MORE THAN USUAL. "MULTIPLE EVENTO INITIAL COMPLAINT NUMBER 96-00082".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTASIS VALVE/SHEATH ASSEMBLY HEMOSTASIS VALVE/SHEATH ASSEMBLY DSP DATASCOPE CORPORATION 0684-00-0211-01 12/22/97

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN