BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRUITT AORTIC OCCLUSION CATHETER

    MDR report key: 2425960 · Received January 12, 2012

    Report

    Report Number
    1220948-2012-00001
    Event Type
    Death
    Date Received
    January 12, 2012
    Date of Event
    November 28, 2011
    Report Date
    December 13, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DQT
    PMA / PMN Number
    K872090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE HAS BEEN RETURNED FOR THE EVALUATION ON (B)(4) 2012. THE SECOND DEVICE WAS DISCARDED - CAT NUMBER 2100-12, LOT PAO1058 (MFG 02/2009, EXP 12/31/2011). WE WERE ABLE TO VERIFY AND CONFIRM THE FAILURE OF ONE DEVICE. WE HAVE FOUND THAT BALLOON HAD HOLES AND WAS DEGRADED. THE ROOT CAUSE OF BALLOON DEGRADATION REMAINS INCONCLUSIVE. HOWEVER, SOMETIMES SIGNS OF DEGRADATION APPEAR BEFORE SHELF LIFE EXPIRATION DUE TO STORAGE CONDITIONS (THE HEAT, LIGHT AND/OR HUMIDITY EXPERIENCED BY THE PACKAGING AND THE DEVICE PRIOR TO USE). SINCE NATURAL RUBBER LATEX IS ACTED ON BY ENVIRONMENTAL CONDITIONS, WE ALWAYS RECOMMEND STORAGE OF OUR PRODUCTS IN A COOL DARK AREA AWAY FROM FLUORESCENT LIGHTS, SUNLIGHT AND CHEMICAL FUMES TO PREVENT PREMATURE DETERIORATION OF THE RUBBER BALLOON. (PLEASE REFERENCE LEMAITRE VASCULAR, INC. IFU FOR MORE DETAILS.) LOT HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES. PLEASE NOTE THAT DESPITE NUMEROUS ATTEMPTS TO CONTACT, WE WERE NOT ABLE TO GET CONFIRMATION FROM THE PHYSICIAN AS TO WHETHER THE FAILURE OF THE PRUITT AORTIC OCCLUSION CATHETER CONTRIBUTED TO THE DEATH OF THIS PATIENT. WE, THEREFORE, ARE SUBMITTING THIS REPORT BASED ON THE REGULATIONS SET FORTH IN 21CFR803.50.

    Description of Event or Problem · 1

    THE PATIENT IN THIS CASE WAS UNDER EMERGENCY CARE FOR A RUPTURED AAA. THE PHYSICIAN REQUESTED THE AORTIC OCCLUSION CATHETER. THE FIRST TWO UNITS HAD DEFECTIVE BALLOONS (BALLOONS WOULD NOT INFLATE) AND WERE NOT USED IN THE PATIENT. THE THIRD UNIT FUNCTIONED PROPERLY AND THE PATIENT WAS STABILIZED. THE PHYSICIAN FINISHED THE PROCEDURE AND THE PATIENT LEFT THE OPERATION ROOM. THE PATIENT LATER EXPIRED IN THE ICU. DESPITE NUMEROUS ATTEMPTS TO CONTACT, WE WERE NOT ABLE TO GET CONFIRMATION FROM THE PHYSICIAN AS TO WHETHER THE FAILURE OF THE PRUITT AORTIC OCCLUSION CATHETER CONTRIBUTED TO THE DEATH OF THIS PATIENT. WE, THEREFORE, ARE SUBMITTING THIS REPORT BASED ON THE REGULATIONS SET FORTH IN 21CFR803.50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT AORTIC OCCLUSION CATHETER PRUITT AORTIC OCCLUSION DQT LEMAITRE VASCULAR 2100-12 PAO1073

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O