BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB-30CC

    MDR report key: 732514 · Received July 6, 2006

    Report

    Report Number
    1219856-2006-00229
    Event Type
    Injury
    Date Received
    July 6, 2006
    Date of Event
    June 21, 2006
    Report Date
    July 6, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED WHEN EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN CONTACTED ARROW CLINICAL SUPPORT (ACS) ADVISING THAT THE AUTOCAT 2 WAVE WAS EXPERIENCING HELIUM LOSS(2) ALARMS. THE PATIENT HAD A 30 CC IAB INSERTED. THE BALLOON AUGMENTATION WAS 120 AND THE BALLOON PRESSURE WAS 130. ACS HAD THE CLINICIAN REMOVE 3 CC OF HELIUM. THE ALARMS CONTINUED. PLACEMENT WAS VERIFIED UNDER X-RAY. THE ALARMS STOPPED. LATER THAT EVENING THE CLINICIAN CALLED BACK TO INFORM ACS THE HELIUM LOSS ALARMS STARTED AGAIN. THE BALLOON WAS DOWN TO 20 CC AND THE PATIENT PERFECTLY STILL WITH NO ECTOPY AND THE RHYTHM IN THE LOW 70S. A CATHETER LEAK WAS SUSPECTED AND THE PHYSICIAN OPTED TO REMOVE THE IAB. THE IAB HAD BEEN INSERTED PRE-OPERATIVELY. A NEW IAB WAS INSERTED THE FOLLOWING DAY PRIOR TO THE SCHEDULED SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. FOLLOW-UP REPORT WILL BE FILED WHEN EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB-30CC INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ARROW AUTOCAT 2 WAVE| X-RAY