MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE SET; GBX CATHETER, IRRIGATION

Model Number	G04137
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the thal-quick chest tube was inadvertently inserted into the left heart of a patient during a chest tube placement procedure to relieve a pleural effusion.A 74-year-old man with a past medical history of chronic obstructive pulmonary disease and cachexia presented to the emergency department with dyspnea and weakness and was admitted to the intensive care unit (icu) for decompensated covid-19 pneumonia.Serial chest radiographs revealed a worsening left-sided pleural effusion.A post graduate year 3 emergency medicine resident physician attempted placement of a 24 french thal-quick catheter chest tube using blunt dissection and the seldinger technique with serial dilations at the third intercostal space at the midaxillary line.Upon removal of the final dilator from the chest tube lumen, pulsatile blood flow was observed, and the chest tube was immediately clamped.The patient remained awake, alert, and received supplemental oxygen with an spo2 > 92% throughout the procedure.Immediately thereafter, his mean arterial pressure decreased to 58 mmhg.A chest x-ray was performed and suggested the chest tube being in the left heart.The patient was emergently taken to the operating room for tracheal intubation, echocardiography, surgical exploration and repair.A transesophageal echocardiogram (tee) showed signs of early pericardial tamponade, the chest tube entering the left ventricle through the lateral wall, passing through the left ventricular outflow tract, and through the aortic valve.After sternotomy, the chest tube's path was directly visible through the chest wall into the heart.Echocardiography revealed no damage to the aortic valve or additional intracardiac injury.The chest tube was removed and the left ventricular free wall injury was repaired primarily with a bovine pericardial patch while on cardiopulmonary bypass.After separation from cardiopulmonary bypass, tee confirmed adequacy of repair, normal ventricular and valve function, and resolution of hemopericardium.After restoring hemodynamic stability, the patient was returned to the icu.The patient's hemodynamic course improved post-operatively with good cardiac surgical results and weaning of vasopressors.The patient was subsequently discharged to a long-term care facility.Several weeks thereafter the patient developed septic shock and respiratory failure.The family requested comfort care measures and the patient subsequently expired.Literature citation: guerra, j.L., ikonomakou-nikolaidis, s., and culp jr, w.C.(2024).Iatrogenic intracardiac chest tube: echocardiographic diagnosis and management.Jca advances, 100052.Doi: https://doi.Org/10.1016/j.Jcadva.2024.100052.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 - pma/510(k) #: exempt.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: d4 - lot #, udi, expiration date, h6- annex a investigation ¿ evaluation on 23sep2024, cook was informed of an issue with a thal-quick chest tube set.Per the provided literature, it was reported that a patient undergoing a chest tube placement experienced an issue of the chest tube being placed in the left ventricle.The chest tube was removed and the left ventricle wall was repaired with a bovine pericardial patch.The patient was moved to the icu after restoring hemodynamic stability.The patient¿s condition improved post-operatively and was discharged to a long-term care facility.Reviews of the documentation, including the complaint history, device history record and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded there are no relevant inspections for this failure mode.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed 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 gathered upon review of the product ifu and dhr, 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 our investigation, cook concluded that the cause of event to be an unintended use error.It¿s possible that due to the nature of the emergency provided in the literature article, the chest tube was over inserted and punctured the left ventricle.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.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20326993
• Report Number: 1820334-2024-01281
• Device Sequence Number: 18088343
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)231124(10)13586619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: G04137
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 13586619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male