BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 137784 · Received December 8, 1997

    Report

    Report Number
    2248146-1997-01327
    Event Type
    Malfunction
    Date Received
    December 8, 1997
    Date of Event
    November 23, 1997
    Report Date
    November 25, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738 DEVICE LABEL CODE FOR F10. POSITION 2: 1738 DEVICE LABEL CODE FOR F10. POSTION 3: - EVALUATION SUMMARY: THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE IAB AND WITHIN THE INNER LUMEN. THE SHEATH USED WITH THE IAB (AS INDICATED ON THE RETURNED DATASHEET OR DURING THE INITIAL COMPLAINT REPORT) WAS NOT RETURNED FOR EVALUATION. THE CATHETER O.D. WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MANUFACTURING SPECIFICATIONS. THE FOLDED MEMBRANE APPEARED NORMAL UNDER ROOM LIGHT AND POLARIZED LIGHT. AS A TEST, A VACUUM WAS DRAWN ON THE FOLDED MEMBRANE USING A LAB 60 CC. SYRINGE AND ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH A LAB 10 FRENCH, 11 INCH SHEATH WITHOUT ANY DIFFICULTIES. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE BALLOON'S FOLDED MEMBRANE OR IN THE IAB CATHETER. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. HAVING THE OPPORTUNITY TO EXAMINE THE ORIGINAL SHEATH USED WITH THE IAB MAY HAVE PROVIDED SOME ADDITIONAL INSIGHT INTO THE ENCOUNTERED PROBLEM. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH 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 PATIENT 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.

    Description of Event or Problem · 1

    EVENT: CC# 97-01421) THE DR WAS UNABLE TO INSERT THE IAB INTO THE PT. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 1/19/1998: THE IAB COULD NOT BE ADVANCED THROUGH THE 11" SHEATH. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 11/25/1997; NONE - RPT'D 1/19/1998. [PT'S CURRENT STATUS]: UNKNOWN - RPT'D 11/25/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0306 11/07/99

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR