BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR 25CC IAM

    MDR report key: 3931250 · Received June 23, 2014

    Report

    Report Number
    2248146-2014-00130
    Event Type
    Death
    Date Received
    June 23, 2014
    Date of Event
    May 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE PRESSURE AND EXTENSION TUBING WERE ALSO RETURNED. PRODUCT EVALUATION - AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL, AND EXTENSION PRESSURE TUBING WAS PERFORMED AND ONE LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 3.3CM FROM THE REAR SEAL MEASURING 0.038CM IN LENGTH. CONCLUSION: UNDER MAGNIFICATION, A WHITISH PATH WAS OBSERVED AROUND THE LEAK. THIS WHITISH PATCH IS THE TYPICAL APPEARANCE OF AN ABRASION MARK WHICH IS CAUSED BY CALCIFIED PLAQUE IN THE AORTA. (B)(4).

    Description of Event or Problem · 1

    AT 3:31AM RECEIVED A CALL FROM CATHETER LAB AND TOLD ME THAT THEY HAD PT IN THE CVICU WHO WAS ON THE BALLOON PUMP WITH A "RUPTURED" CATHETER. HE DESCRIBED IT AS "BLOOD INSIDE THE TUBING". HE COULDN'T STAY ON THE PHONE, BECAUSE THEY WERE TALKING THE PT BACK TO CVOR. HIS QUESTION WAS COULD THEY REWIRE THE LUMEN AND THEN REPLACE THE BALLOON. I TOLD HIM THAT WE DO NOT RECOMMEND HAVING THAT DONE. HE SAID HE HAD TO GO BECAUSE HE NEED TO GO BACK TO THE PT, AND TO GET THE INFO IN THE MORNING. AT 8:45AM, I CALLED THIS MORNING AND SPOKE WITH DIRECTOR OF CVICU, AN SHE SAID THAT THEY PULLED THE BALLOON AND BELIEVED THAT THE BALLOON WAS IN THE PERFUSION DEPT. SHE TOLD ME THAT THE PT WAS DOING WELL. I CALLED PERFUSION, AND WAS TOLD THAT THEY HAVE THE BALLOON BUT I HAVE TO CALL BACK AND TALK TO GET ALL THE INFO BECAUSE HE WAS IN A CASE. H EIS NOT COMING IN UNTIL THE AFTERNOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366794 LINEAR 7.5 FR 25CC IAM INTRA-AORTIC BALLOON DSP DATASCOPE CORP 0684-00-0473 2725

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death