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

Model Number N/A

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

It was reported that the wire guide of a thal-quick chest tube set unraveled and elongated upon removal from the patient's chest during pneumothorax drainage in the emergency unit.When removing the product from the patient, the nurse discovered that the wire guide had, "relaxed and unfolded." the drain was then removed from the patient and a new one was placed.Photos of the complaint device provided by the customer showed the wire guide to be unraveled and elongated.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(6).Occupation: unknown.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.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) , in france, reported to cook that during a pneumothorax drainage procedure, the wire guide was noted to be ¿relaxed¿ when it was removed from the patient.The customer provided a photograph of an unraveled and elongated wire guide for the investigation (rpn: c-tqts-1000, lot: unknown).The wire guide was removed from the patient, and a new drain was placed.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation including the complaint history, instructions for use (ifu),quality control procedures of the device, as well as a visual inspection of a provided photo of the complaint device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a photograph provided by the facility showed the wire guide to be in an unraveled state.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that the product is 100% inspected during the manufacturing process for defects.Sales to the customer were reviewed and yielded six possible lot numbers for the complaint device (9110039, 9550142, 9676630, 13673397, 13917335 and 13956464).A review of the device history record (dhr) for these lot numbers found relevant nonconformances that could have contributed to the reported failure mode; however, nonconforming devices were scrapped per the 100% quality control inspection.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet c_t_thal_rev11.In the instructions for use section, it states: 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: if resistance is encountered during chest tube assembly insertion, determine the cause of resistance, and take necessary action to relieve resistance before proceeding.Note: it is important to advance the chest tube assembly into the pleural space in the same line as the wire guide.This will make introduction easier and avoid kinking of the wire guide.Note: the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide.10) remove the wire guide and chest tube inserter, leaving the chest tube in place.(fig.4) in the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Evidence provided by the device master record review, device history record reviews, and provided photo, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided and the results of our investigation, it was concluded that a component failure without design or manufacturing deficiency contributed to the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: 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: 13458479
• MDR Text Key: 285332342
• Report Number: 1820334-2022-00165
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1