MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562); Unraveled Material (1664)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

E1- customer (person): postal code: (b)(6).G4- 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 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 or that a death or serious injury occurred; nor is it admission 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

It was reported that the guidewire from a wayne pneumothorax set became "stuck" in the chest tube after initial insertion.The chest tube and guide wire were removed; and it was noted upon inspection that the guidewire had unraveled.A chest tube was placed using the seldinger technique.Immediately upon insertion, the guidewire was difficult to remove.The entire wayne catheter and guidewire were subsequently removed together.It was then noted upon inspection that the guidewire had unraveled.The chest tube would have remained in situ, but early discontinuation resulted from the reported procedure malfunction.No subsequent chest tube insertion was required.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.E3: bscn, clinical practice manager.Additional information: b5, e3, d9, f10 -annex a , h6 - annex a.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 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 or that a death or serious injury occurred; nor is it admission 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

The device was received by cook medical.During preliminary evaluation, it was discovered that the device was separated.

Manufacturer Narrative

On 25jul2023, the wire guide of a wayne pneumothorax set unraveled and separated.The insertion of the needle and wire guide was smooth and uneventful but the patient was moving slightly during insertion of pigtail.The patient had a chronic cough and also had some shortness of breath prior to tube insertion.After placing the wayne catheter the customer attempted to remove the wire guide and had difficulties.After the wire guide was removed from the catheter, the physician noticed it had unraveled and separated; in return, the catheter and the portion of the separated wire guide inside the catheter were removed.No subsequent chest tube insertion was required.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used wire guide and catheter were returned to cook for evaluation.The catheter had no damage noted and the straightening obturator was missing.The distal portion of the wire guide was missing, and the inner core of the wire guide was protruding from the coils.The wire guide's outer diameter was measured and found to be out of specification.The appropriate manufacturing personnel were informed of this failure.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Additional final lots containing the same wire guide sub assembly lot were reviewed.No other complaints or related non-conformances were found from these lots.An additional expanded dhr was performed.Additional wire guide sub assembly lots between mar06-mar10 were also reviewed.The sub assembly lots did have non-conformances related to damaged wire, but the product is 100% inspected and non-conforming material was scrapped.The final lots containing those sub-assembly lots were also reviewed.There was one complaint reported from the field unrelated to the failure of this complaint.Cook also reviewed product labeling.The product ifu, [c_t_waynemod_rev5] ¿wayne pneumothorax set for seldinger placement,¿ provides the following information to the user related to the reported failure mode: instructions for use ¿7.Attach plastic three-way stopcock to the catheter obturator.Fully straighten the curved catheter tip by advancing the catheter obturator.When fully advanced, attach the obturator to the catheter via the luer lock connection.8.Advance the catheter over the wire guide into the pleural cavity to the desired depth.9.Remove the wire guide and catheter obturator.¿ the information provided upon review of device failure analysis identified non-conforming material.The information provided in the dmr, product labeling, dhr, does not indicate any additional devices were manufactured out of specification.There is no evidence of additional nonconforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded component failure as the cause for this event.The damage might have been caused by the patient reportedly moving during the catheter insertion, but cook cannot definitively confirm this.The wire guide outer diameter was found to be slightly below specification, but that is likely not the main contributing factor to it becoming stuck.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.

Event Description

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

Event Description

Per additional information provided on 10oct2023, insertion of the needle and wire guide went smoothly and was successful.During insertion of the catheter, the patient was slightly moving possibly due to the pre-existing conditions, chronic cough and shortness of breath.It was clarified that after the wire guide was removed from the catheter, the physician noticed it had unraveled and separated; in return, the catheter and the portion of the separated wire guide inside the catheter were removed.The physician also commented the patient was "much improved" following the drainage of the pleural effusion.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b7 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 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 or that a death or serious injury occurred; nor is it admission 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: WAYNE PNEUMOTHORAX SET
• Type of Device: JOL CATHETER AND TIP, SUCTION
• 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: 17429911
• MDR Text Key: 320502405
• Report Number: 1820334-2023-00989
• Device Sequence Number: 1
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)241230(10)15373152
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 15373152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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