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	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After placing the thal-quick chest tube catheter for chest drainage, the physician removed the wire guide and found it to be unraveling.The patient did not require any additional procedures due to the unraveling of the wire guide and did not experience any adverse effects.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Phone: (b)(6).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
Canned language: blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation a representative of ospedale bassini (italy) informed cook on 20mar2023 of an issue with a thal-quick chest tube set (rpn: c-tqts-2400; lot #: 13695771).The customer reported that when the wire was removed after drainage positioning, the wire was noticed to be unraveled.No additional procedures were required due to this occurrence.No adverse effects have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 also reviewed the device history record (dhr).The dhr for lot 13695771 records no nonconformances.Wire guide subassembly lot ic13554495 showed one possibly related nonconformance for ¿solder broken.¿ wire guide subassembly lot ic13554500 showed one possibly related nonconformance for ¿wire broken.¿ all nonconforming devices have been scrapped per qc prior to further production.A review of the complaint database found no additional wire-related complaints from this lot.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 evidence gathered from review of the dmr, dhr, and ifu, 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.Based on the information provided, no returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The customer reported that when the wire was removed after drainage positioning, the wire was noticed to be damaged.It is possible that the multiple devices that are advanced over the wire guide while it is in place, could have contributed to the damage, however this cannot be confirmed.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: 16592195
• Report Number: 1820334-2023-00294
• Device Sequence Number: 4937397
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)240118(10)13695771
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 01/18/2024
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 13695771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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