BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1820334-2019-01090

    MDR report key: 8615930 · Received May 16, 2019

    Report

    Report Number
    1820334-2019-01090
    Event Type
    Injury
    Date Received
    May 16, 2019
    Report Date
    July 24, 2019
    Manufacturer
    COOK INC
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED FOR COOK AIRWAY EXCHANGE CATHETERS. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE LOSS OF USE FAILURE MODE AND IDENTIFIES THE RISK CONTROLS THAT ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE.NO LOT NUMBER WAS PROVIDED; THEREFORE, A REVIEW OF NON-CONFORMANCES CANNOT BE COMPLETED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED AT THAT TIME. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MCLEAN, S., MD, LANAM, C. R., BENEDICT, W., BS, KIRKPATRICK, N., BS, KHETERPAL, S., MD, MB, & RAMACHANDRAN, S. K., MD, FRCA. (2013). AIRWAY EXCHANGE FAILURE AND COMPLICATIONS WITH THE USE OF THE COOK AIRWAY EXCHANGE CATHETER®. ANESTHESIA & ANALGESIA, 117(6), 1325-1327. DOI:10.1213/ANE.0B013E3182A7CD3D. THERE WAS NO OTHER INFORMATION PROVIDED EXCEPT WHAT HAS BEEN REPORTED IN THE EVENT DESCRIPTION. A COOK AIRWAY EXCHANGE CATHETER WAS REPORTED. NO SPECIFIC RPN WAS PROVIDED. COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. OTHER RELATED REPORT NUMBERS ORIGINATING FROM THIS ARTICLE INCLUDE: 1820334-2019-01182, 1820334-2019-01183, 1820334-2019-01088, 1820334-2019-01089, 1820334-2019-01091, 1820334-2019-01092, 1820334-2019-01093, 1820334-2019-01094, AND 1820334-2019-01095. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITERATURE FROM ANESTHESIA & ANALGESIA JOURNAL THAT EIGHT PATIENTS EXPERIENCED A PNEUMOTHORAX AFTER THE USE OF A COOK AIRWAY EXCHANGE CATHETER (CAEC). INCLUSION CRITERIA WERE ADULT (OVER THE AGE OF 18) PATIENTS UNDERGOING GENERAL ANESTHESIA IN WHICH A CAEC WAS USED DURING INTUBATION, FOR TUBE EXCHANGE, OR AS AN EXTUBATION AID FROM JUNE 2006 TO OCTOBER 2012. THIS REPORT IS TO CAPTURE THE THIRD OF EIGHT PATIENTS WHO EXPERIENCED A PNEUMOTHORAX AFTER THE USE OF A CAEC. PATIENT THREE HAD A THYROIDECTOMY. AN UNCOMPLICATED SINGLE LUMEN TUBE TO SINGLE LUMEN TUBE EXCHANGE OVER THE CAEC TOOK PLACE. THE PATIENT PRESENTED WITH A TENSION PNEUMOTHORAX AND CARDIOVASCULAR COLLAPSE DURING THE SURGERY. NO SPECIFIC RPN WAS PROVIDED FOR THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME, PATIENT DEMOGRAPHICS, AND TREATMENT OF THE TENSION PNEUMOTHORAX OR CARDIOVASCULAR COLLAPSE DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410537 BTR COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening