BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 5822218 · Received July 26, 2016

    Report

    Report Number
    1820334-2016-00053
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 15, 2015
    Manufacturer
    COOK INC
    Product Code
    LRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: LRC, INSTRUMENT, ENT MANUAL SURGICAL. (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND MANUFACTURING INSTRUCTIONS OF THE PRODUCT WAS CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. IT IS POSSIBLE THAT A HIGHER PRESSURE WAS EXERTED THROUGHOUT THE BALLOON THAN INTENDED, CAUSING THE BALLOON TO APPEAR POROUS AND REQUIRE REPLACEMENT. BASED ON THE INFORMATION PROVIDED WITHOUT THE RETURNED COMPLAINT DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING AN ENDOTRACHEAL TUBE REPLACEMENT PROCEDURE DUE TO A POROUS BALLOON, THE REPORTER LISTS BILATERAL PNEUMOTHORAX AND CARDIAC ARREST AS CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED ON 12JAN2016 DETERMINED THIS EVENT TO BE REPORTABLE: ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN EXTERNAL CARDIAC MASSAGE AND BILATERAL DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475014 COOK AIRWAY EXCHANGE CATHETER LRC COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other