BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 135210 · Received November 25, 1997

    Report

    Report Number
    2248146-1997-01277
    Event Type
    Injury
    Date Received
    November 25, 1997
    Date of Event
    October 15, 1997
    Report Date
    November 11, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE IAB WAS REC'D INTACT FOR EVAL WITH THE MEMBRANE COMPLETELY UNFOLDED WITH BLOOD NOTED ON THE EXTERIOR OF THE MEMBRANE AND WITHIN THE INNER LUMEN. NO SHEATH WAS NOTED TO BE ON THE DEVICE. VISUAL EXAMINATION REVEALED NO KINKS IN THE CATHETER TUBING OR INNER LUMEN. THE IAB PUMPED SATISFACTORILY ON THE LAB SYS 97 AT 100 AND 140 BPM. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE IAB WHICH WOULD HAVE CAUSED THE DEVICE NOT TO DEFLATE AS REPORTED BY THE USER. THE PHYSICAL CONDITION OF THE RETURNED IAB IS NOT QUITE CONSISTENT WITH THAT OF AN IAB IN WHICH DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE PT. UNFORTUNATELY, IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE ENCOUNTERED PROBLEM. DIFFICULTY REMOVING THE IAB FROM THE PT MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: A KINK IN THE CATHETER TUBING TRAPPED HELIUM IN THE MEMBRANE PREVENTING IT FROM FULLY COLLAPSING UNDER NORMAL ARTERIAL PRESSURE ALLOWING FOR EASY REMOVAL OF THE BALLOON FROM THE PT. THE PT'S ANATOMY. DURING IAB REMOVAL, THE MEMBRANE BECAME "BUNCHED" CAUSING INCREASED RESISTANCE DURING IAB REMOVAL.

    Description of Event or Problem · 1

    THE DR WAS UNABLE TO INSERT THE IAB INTO THE SHEATH. (ON 12/11/97, DATASCOPE REC'D THE VOLUNTARY MEDWATCH FORM FROM THE FDA: MDR ACCESS NUMBER: 1012497; TRIAGE UNIT SEQUENCE NUMBER: 73380). THE FOLLOWING WAS REPORTED TO DATASCOPE ON 12/11/976: AFTER THE IAB WAS INSERTED INTO THE PT, IT WOULD NOT DEFLATE. DURING IAB REMOVAL, THE ARTERY WAS TORN. THE PT WAS TAKEN TO THE OR FOR REPAIR TO THE RIGHT FEMORAL ARTERY. THE IAB IS NOT AVAILABLE FOR EVAL. (MULTIPLE EVENT TO CC# 97-01365). THE FOLLOWING WAS REPORTED TO DATASCOPE ON 1/12/98: THE IAB WOULD NOT DEFLATE. WHEN THE IAB WAS REMOVED, THE PT'S ARTERY GOT TORN. THE PT WAS BROUGHT TO THE OR FOR REPAIR TO THE ARTERY. [EVENT COMPLICATIONS]: UNK-RPT'D 11/11; TORN ARTERY REQUIRING REPAIR-RPT'D 12/11. [PT'S CURRENT STATUS]: LIVING-RPT'D 1/12/98.

    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 CORPORATION 0684-00-0269 06/06/99

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention