BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 147191 · Received January 28, 1998

    Report

    Report Number
    2248146-1998-00055
    Event Type
    Malfunction
    Date Received
    January 28, 1998
    Date of Event
    December 15, 1997
    Report Date
    January 15, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, IF ANY, 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, 6 INCH SHEATH WITHOUT DIFFICULTY. 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/HEMOSTASIS VALVE ASSEMBLY (USED WITH THE IAB) MAY HAVE PROVIDED SOME ADDITIONAL INSIGHT INTO THE ENCOUNTERED PROBLEM. IN GENERAL, DIFFICULTY ADVANCING THE IAB OR SHEATH INTO THE PATIENT OR 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# 98-0056) THE DR WAS UNABLE TO ADVANCE THE IAB INTO THE SHEATH. A SECOND IAB WAS USED WITH THE SAME SHEATH WITHOUT ANY PROBLEMS. ON 2/20/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: A 6 FRENCH SHEATH WAS INSERTED INTO THE PT VIA AN ARTERAIL PUNCTURE WITHOUT DIFFICULTY. A 0.032" GUIDEWIRE WAS INSERTED THROUGH THE 6 FRENCH SHEATH AND EXCHANGED FOR THE SHEATH. THE WIRE WAS LEFT IN THE PT DURING THE EXCHANGE. THE BALLOON WAS PREPARED PER DATASCOPE'S POLICY AND INSERTED OVER THE GUIDEWIRE. THE BALLOON WOULD NOT ADVANCE INTO THE SHEATH. IT KEPT KINKING. ANOTHER IAB WAS OPENED AND INSERTED WITHOUT DIFFICULTY USING THE SAME SHEATH. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT WAS EVENTUALLY DISCHARGED FROM THE FACILITY. [EVENT COMPLICATION]: NONE FROM THE EVENT - REPORTED 1/15/1998 AND 2/20/1998. [PT'S CURRENT STATUS]: DISCHARGED-RPT'D 2/20/1998.

    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. 0684-00-0283 11/10/99

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR