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

Model Number	G05161
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6).G4 - pma/510(k) #: exempt.H3 - device evaluated by mfg?: device evaluation anticipated but has 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 a guidewire from a thal-quick chest tube set unraveled during use.Resistance or a "snagging sensation" was met upon insertion of the guidewire into the needle.When the guidewire was removed, it was noted to be "frayed".No "back and forth movement" of the guidewire within the needle was reported.No unintended portion of the device remained inside the patient.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that a guidewire from a thal-quick chest tube set unraveled during use.Resistance or a "snagging sensation" was met upon insertion of the guidewire into the needle.When the guidewire was removed, it was noted to be "frayed".No "back and forth movement" of the guidewire within the needle was reported.The physician used a guide from another set to complete the procedure.No unintended portion of the device remained inside the patient.No adverse effects or additional procedures for the patient were reported due to this occurrence.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used wire guide was received inside of a wire guide holder.The safety wire was found to be protruding from the wire at the distal end.The weld ball was intact.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device lot and related subassembly lots found one relevant nonconformance that could have contributed to the reported failure mode, in which all the nonconforming products were scrapped.It should be noted that there were no other complaints associated with the final product lot number.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: ¿instructions for use 5.When the appropriate drainage site has been identified, advance the soft ¿j¿ end of the wire guide through the needle and into the pleural space.Note: the wire guide should pass through the needle and advance into the pleural space without resistance.Note: the skin level marker on the distal end of the wire guide can be used as an insertion depth marker on patients with normal anatomy.Note: due to anatomical variations in chest wall thickness, insertion depth of introducer needle, wire guide and dilators will vary from patient to patient.¿ evidence gathered upon review of dmr, product ifu, dhr, and device failure analysis, 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It¿s possible that the wire guide became caught on the distal tip of the needle, however this cannot be confirmed without additional information.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.
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
Additional information: b3, b5.Correction: h6 - annex e and annex f.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
In additional information received on 25jul2025, it was reported that the physician used a guide from another set to complete the procedure.

• 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: 22612983
• Report Number: 1820334-2025-00895
• Device Sequence Number: 5494292
• Product Code: GBX
• UDI-Device Identifier: 00827002051614
• UDI-Public: (01)00827002051614(17)271101(10)16323578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2025

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: 16323578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/23/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/01/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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