BEUDAMED
    FDA Adverse Event Death Summary report: N

    THAL-QUICK CHEST TUBE TRAY

    MDR report key: 23809668 · Received December 15, 2025

    Report

    Report Number
    1820334-2025-01555
    Event Type
    Death
    Date Received
    December 15, 2025
    Date of Event
    October 28, 2025
    Report Date
    March 19, 2026
    Manufacturer
    COOK INC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 - ANNEX A. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE CATHETER FROM A THAL-QUICK CHEST TUBE TRAY PENETRATED THE RIGHT LUNG AND HEART. THE DEVICE WAS PLACED EMERGENTLY IN A RAPIDLY DECOMPENSATING 69-YEAR-OLD FEMALE PATIENT TO TREAT A PRESUMED PNEUMOTHORAX/PLEURAL EFFUSION. AFTER THE DEVICE WAS PLACED, THE PATIENT REMAINED CLINICALLY UNSTABLE AND PROGRESSED TO CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR). BLOOD RETURN WAS NOTED WHEN THE CHEST TUBE CATHETER WAS CONNECTED TO A WATER SEAL DRAINAGE SYSTEM. THE PATIENT EXPIRED. A POSTMORTEM AUTOPSY REVEALED THE CHEST TUBE APPEARED TO HAVE PENETRATED THE RIGHT LUNG, TRAVERSED THE RIGHT ATRIUM, AND EXITED AT THE APEX OF THE HEART. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION OF THE DEVICE COULD NOT BE COMPLETED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT THERE WERE NO RELEVANT INSPECTIONS FOR THIS FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION. COOK ALSO REVIEWED THE PRODUCT LABELING. THE PRODUCT IFU, [C_T_THAL_REV11] ¿THAL-QUICK CHEST TUBE SETS AND TRAYS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿WARNINGS OVER-INSERTION OF THE COAXIAL CHEST TUBE INSERTER AND CLEAR CATHETER ASSEMBLY MAY RESULT IN SERIOUS OR LIFE-THREATENING INJURY. CLINICAL JUDGEMENT, AND CONSIDERATION OF PATIENT SIZE AND ANATOMY SHOULD GUIDE APPROPRIATE CHEST TUBE SELECTION (E.G., SIZE FRENCH, LENGTH, NUMBER OF SIDEPORTS) AND INSERTION. NOTE: TO MAINTAIN AN AIR TIGHT DRAINAGE SYSTEM AND AVOID FURTHER COMPLICATIONS, IT IS IMPORTANT THAT ALL SIDEPORTS OF THE CHEST TUBE ARE POSITIONED WITHIN THE PLEURAL SPACE. THE CENTIMETER MARKINGS ON THE CHEST TUBE DENOTE THE DISTANCE FROM THE MOST PROXIMAL SIDEPORT (I.E., THIS IS NOT THE DISTANCE FROM TIP OF THE CATHETER). THESE MARKINGS CAN BE USED AS A REFERENCE WHILE ESTABLISHING APPROPRIATE DEVICE POSITIONING. ¿INSTRUCTIONS FOR USE 9 ¿ WITH THE WIRE GUIDE STILL POSITIONED WITHIN THE PLEURAL SPACE, ADVANCE THE CHEST TUBE INSERTER/CHEST TUBE ASSEMBLY OVER THE WIRE GUIDE AND INTO THE PLEURAL SPACE. NOTE: REMOVE THE WIRE GUIDE AND CHEST TUBE INSERTER, LEAVING THE CHEST TUBE IN PLACE.¿ EVIDENCE PROVIDED BY A REVIEW OF THE CURRENT PRODUCT IFU, THERE IS NO INDICATION THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THIS INVESTIGATION, IT WAS CONCLUDED THAT AN ADVERSE EVENT RELATED TO THE PROCEDURE CONTRIBUTED TO THE REPORTED EVENT. IT IS POSSIBLE THAT DUE TO THE NATURE OF THE EMERGENCY PROVIDED IN THE REPORT, THE CHEST TUBE WAS OVER INSERTED AND PUNCTURED THE LUNG. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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.

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH: NOT SPECIFIED. G4 - PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATED BY MFG? NO DEVICE RETURN TO MANUFACTURER ANTICIPATED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER FROM A THAL-QUICK CHEST TUBE TRAY PENETRATED THE RIGHT LUNG AND HEART. THE DEVICE WAS PLACED EMERGENTLY IN A RAPIDLY DECOMPENSATING 69-YEAR-OLD FEMALE PATIENT TO TREAT A PRESUMED PNEUMOTHORAX/PLEURAL EFFUSION. AFTER THE DEVICE WAS PLACED, THE PATIENT REMAINED CLINICALLY UNSTABLE AND PROGRESSED TO CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR). BLOOD RETURN WAS NOTED WHEN THE CHEST TUBE CATHETER WAS CONNECTED TO A WATER SEAL DRAINAGE SYSTEM. THE PATIENT EXPIRED. A POSTMORTEM AUTOPSY REVEALED THE CHEST TUBE APPEARED TO HAVE PENETRATED THE RIGHT LUNG, TRAVERSED THE RIGHT ATRIUM, AND EXITED AT THE APEX OF THE HEART. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272369 THAL-QUICK CHEST TUBE TRAY GBX; CATHETER, IRRIGATION GBX COOK INC G04226 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death