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

Model Number	G05161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6).G4 ¿ pma/510(k) #: exempt.H3 - device evaluation anticipated but not yet begun.Awaiting device return.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
It was reported that the guidewire included in a thal-quick chest tube set separated.A thal-quick chest drain was being placed in an unknown patient with pleural fluid.The procedure progressed without issue until the stage where the guidewire was to be withdrawn through the drain.At this point, resistance was encountered while attempting to remove the wire.In response, the entire drain was withdrawn from the patient.Upon inspection by the user, it was noted that the guidewire had partially fractured, with a segment of the wire remaining inside the thoracic cavity.The retained wire fragment was subsequently retrieved in full.Examination of the wire revealed that one strand of the steel wire had broken, and the remaining wires exhibited signs of twisting.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.

• 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: 24717830
• Report Number: 1820334-2026-00335
• Device Sequence Number: 5763742
• Product Code: GBX
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G05161
• Device Catalogue Number: C-TQTS-1200
• Device Lot Number: 16625694
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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
• Patient Sex: Unknown