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	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): postal code: (b)(6).Occupation: risk management.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
It was reported that the wire included in the thal-quick chest tube set had unraveled upon removal during a chest tube insertion.Initial placement of the wire was quick and easy.The dilator and the thal-quick chest tube advanced easily.The user reported rotating "a half turn or so," when advancing the dilator.No kinking of the wire was observed upon advancement into the tubes.Difficulty was experienced when attempting to remove the wire guide from the tube, as the physician was unable to advance or retract the dilator from the guidewire.When the wire was finally pulled out of the chest tube, it was reported that "the wire was noticeably broken and had folded back upon itself and jammed in the dilator." a 1cm section of the wire was discovered to be unraveled/stretched.The patient required to have the procedure restarted, resulting in additional invasive chest wall access.No other harm to the patient has been reported.
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
Investigation ¿ evaluation: red deer regional hospital in canada informed cook on 24may2022 of an issue with a thal-quick chest tube set ((b)(6) , lot# 14463177).The customer stated the initial wire placement on 18may2022 was quick and easy.The dilator and thal-quick chest tube advanced easily.Difficulty occurred while removing the wire from the chest tube.When the surgeon pulled the chest tube and wire out, it was noted that the wire was slightly unraveled/stretched over a 1cm section.The wire did not seem to kink at all when inserted into the tubes.The user rotated a half turn or so when advancing the dilator.The procedure had to be restarted due to this occurrence.No other harm to the patient was reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures of 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 reviewed the device history record (dhr).The dhr for lot 14463177 records no relevant non-conformances or complaints.Cook also reviewed wire guide subassembly lot ic14358820.There are 3 nonconformances on this lot.2 of them are possibly related for the failure of ¿solder, broken.¿ all nonconforming product is scrapped and checked 100% per qc prior to further production.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: 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 side ports 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.¿ evidence gathered from reviews of the dmr, product labeling (ifu), and dhr, 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, no returned device, and the results of the investigation, it was determined the cause of this event is related to component failure, without evidence of manufacturing deficiency.It is possible the wire became kinked after advancement, causing the reported failure to occur during removal.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: 15121882
• Report Number: 1820334-2022-01292
• Device Sequence Number: 14887028
• Product Code: GBX
• UDI-Device Identifier: 00827002051614
• UDI-Public: (01)00827002051614(17)250110(10)14463177
• 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
• Report Date (Section B): 11/14/2022

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: 01/10/2025
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1200
• Device Lot Number: 14463177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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