BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 6648318 · Received June 16, 2017

    Report

    Report Number
    1820334-2017-01296
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    September 21, 2017
    Manufacturer
    COOK INC
    Product Code
    LRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. THE LOT NUMBER IS UNKNOWN, THEREFORE A REVIEW OF THE WORK ORDER, POTENTIAL NONCONFORMANCES AND RELATED COMPLAINTS COULD NOT BE PERFORMED. THE IFU PROVIDED WITH ALL COOK CAE CATHETERS INCLUDES WARNINGS AND PRECAUTIONS SURROUNDING THE DEPTH OF CATHETER PLACEMENT. QUALITY CONTROL STEPS ARE IN PLACE TO ENSURE THAT THE CATHETER CONTAINS PROPER DEPTH MARKINGS AND THAT THERE IS NO DAMAGE TO THE DEVICE. A DOCUMENT-BASED INVESTIGATION EVALUATION SHOWED NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. AS STATED IN THE JOURNAL ARTICLE AND AS CONCLUDED BY THIS INVESTIGATION, THE ROOT CAUSE OF PNEUMOTHORAX DEVELOPMENT IS UNKNOWN. THE COMPLAINT IS CONFIRMED BASED ON THE TESTIMONY WITHIN THE JOURNAL ARTICLE. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    HARRIS, K, CHALHOUB, M, MAROUN, R, ELSAYEGH, D; ENDOTRACHEAL TUBE EXCHANGERS: SHOULD WE LOOK FOR SAFER ALTERNATIVES? HEART & LUNG 41 (2012) 67-69. THE ABOVE REFERENCED ARTICLE REPORTS THAT A (B)(6) MALE PATIENT, PRESENTED TO THE AMBULATORY SUITE FOR CIRCUMCISION. THE PATIENT WAS INTUBATED USING A VIDEO LARYNGOSCOPE, WITHOUT REPORTED DIFFICULTY. ABOUT 30 MINUTES INTO THE PROCEDURE, THE ANESTHESIOLOGIST NOTICED A SIGNIFICANT DECREASE IN TIDAL VOLUME, WITH NO CONCURRENT DROP IN OXYGEN SATURATION. AN ETT BALLOON RUPTURE WAS SUSPECTED. AFTER 2 ATTEMPTS, THE MALFUNCTIONING ETT WAS SUCCESSFULLY EXCHANGED WITH AN 8-MM ETT, USING A COOK AEC (COOK INCORPORATED) (14.0 FRENCH AND 83 CM). WITHIN 5 MINUTES OF THE EXCHANGE, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION, WITHOUT ANY SIGNIFICANT HEMODYNAMIC CHANGES. LUNG AUSCULTATION REVEALED DECREASED AIR ENTRY OVER THE RIGHT CHEST. THE PROCEDURE CONTINUED; THE ANESTHESIOLOGIST SUSPECTED A PNEUMOTHORAX AND CHEST RADIOGRAPH CONFIRMED A LARGE RIGHT SIDE PNEUMOTHORAX; CHEST TUBE WAS PLACED. A BRONCHOSCOPIC EXAMINATION REVEALED NORMAL TRACHEAL AND BRONCHIAL MUCOSA, WITHOUT EVIDENCE OF TRAUMATIC INJURIES, LACERATIONS, OR TEARS. THE PATIENT RECOVERED, CHEST TUBES EXPLANTED ON POST-OP DAY TWO AND PATIENT DISCHARGED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    HARRIS, K, CHALHOUB, M, MAROUN, R, ELSAYEGH, D; ENDOTRACHEAL TUBE EXCHANGERS: SHOULD WE LOOK FOR SAFER ALTERNATIVES? HEART AND LUNG 41 (2012) 67-69. THE ABOVE REFERENCED ARTICLE REPORTS THAT A (B)(6) MALE PATIENT, PRESENTED TO THE AMBULATORY SUITE FOR CIRCUMCISION. THE PATIENT WAS INTUBATED USING A VIDEO LARYNGOSCOPE, WITHOUT REPORTED DIFFICULTY. ABOUT 30 MINUTES INTO THE PROCEDURE, THE ANESTHESIOLOGIST NOTICED A SIGNIFICANT DECREASE IN TIDAL VOLUME, WITH NO CONCURRENT DROP IN OXYGEN SATURATION. AN ETT BALLOON RUPTURE WAS SUSPECTED. AFTER 2 ATTEMPTS, THE MALFUNCTIONING ETT WAS SUCCESSFULLY EXCHANGED WITH AN 8-MM ETT, USING A COOK AEC (COOK INCORPORATED) (14.0 FRENCH AND 83 CM). WITHIN 5 MINUTES OF THE EXCHANGE, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION, WITHOUT ANY SIGNIFICANT HEMODYNAMIC CHANGES. LUNG AUSCULTATION REVEALED DECREASED AIR ENTRY OVER THE RIGHT CHEST. THE PROCEDURE CONTINUED; THE ANESTHESIOLOGIST SUSPECTED A PNEUMOTHORAX AND CHEST RADIOGRAPH CONFIRMED A LARGE RIGHT SIDE PNEUMOTHORAX; CHEST TUBE WAS PLACED. A BRONCHOSCOPIC EXAMINATION REVEALED NORMAL TRACHEAL AND BRONCHIAL MUCOSA, WITHOUT EVIDENCE OF TRAUMATIC INJURIES, LACERATIONS, OR TEARS. THE PATIENT RECOVERED, CHEST TUBES EXPLANTED ON POST-OP DAY TWO AND PATIENT DISCHARGED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428384 COOK AIRWAY EXCHANGE CATHETER LRC COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention