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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire guide included in the thal-quick chest tube set unraveled during a chest tube placement procedure on an unknown pediatric patient.Following placement of the device, the wire was removed from the catheter and the tip was found to be kinked, with the wire being described as "thin and curvy." the unraveled wire guide was able to be completely removed from the patient.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details have been requested but are currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer (person): phone: (b)(4), ext: 15455.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.
Additional Manufacturer Narrative
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
Per additional information provided on 10may2023, the wire was noted to be "fine" before insertion into the needle.The wire most likely kinked in the patient when the user pulled the wire back and the wire got "stuck" on the tip of the needle making it difficult it to pull the wire out.The user had to use a stronger force to pull the wire and was able to remove the wire without any adverse effects to the patient.The wire being manipulated by the needle most likely occurred but the user was not completely sure for this case.
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 unchanged, unknown, or unavailable.Investigation ¿ evaluation.A representative of (b)(6) (germany) informed cook on 14apr2023 of an issue with a thal-quick chest tube set (rpn: c-tqts-1200: lot #: 15182505).The customer stated that when the wire was pulled out, it was unraveled and had changed consistency.Per the company representative, it is likely the wire kinked inside the patient causing the wire to become stuck on the needle tip which resulted in greater force being used.No adverse effects to the patient have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One unused/sealed set along with one used wire guide were returned to cook for evaluation.The used wire guide was stretched and elongated beginning at the solder joint.The inner mandrill exited from the stretched-out coils.No damage was noted to the unused wire guide.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record for lot 15182505 and subassembly lots.There are no nonconformances or additional complaints found for this lot.Based on the dmr, dhr and device failure analysis, there is no indication the complaint device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.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: ¿instructions for use: -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.-remove the needle, leaving the wire guide in place.-while maintaining wire guide position, dilate the tract and opening into the pleural space by advancing, in sequence small to large, the supplied dilators over the wire guide.Introduction into the pleural space is facilitated by rotating and advancing the dilator in line with the wire guide to prevent its kinking.Warning: over insertion of the needle and/or dilators may result in serious harm to the patient.Note: it is important to have enough length of the wire guide exiting the access site to facilitate controlled introduction of the dilators.The dilators only have to enter the pleural space to their full diameter and should never be advanced beyond the distal end of the wire guide.-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.-remove the wire guide and chest tube inserter, leaving the chest tube in place.Note: it is important that all sideports of the chest tube are positioned within the pleural space.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event to be unintended user error.The customer stated that when the wire was pulled out, it was unraveled and had changed consistency.It is likely when the wire guide was manipulated in the needle, it caused damage to the wire guide resulting in the unraveling.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: 16769505
• Report Number: 1820334-2023-00463
• Device Sequence Number: 19646158
• Product Code: GBX
• UDI-Device Identifier: 00827002051614
• UDI-Public: (01)00827002051614(17)260120(10)15182505
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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 Expiration Date: 01/20/2026
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1200
• Device Lot Number: 15182505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 07/11/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/15/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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