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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - customer (person): postal code:(b)(6).E3 - occupation: service coordinator 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.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 wayne pneumothorax set unraveled as the physician removed it from the catheter during device placement to treat pneumothorax in an unknown patient.It is currently unknown if the patient experienced any adverse effects due to this occurrence.Additional information regarding event and patient details has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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provided on 03nov2023, the procedure was completed with the seldinger technique.The wire guide was not manipulated nor withdrawn through the needle.The physician felt a snap while withdrawing the wire guide through the catheter after the needle had already been withdrawn.The patient did not experience any adverse effects nor require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: d9, h3 investigation ¿ evaluation on 18oct2023, it was reported that the guidewire included in the wayne pneumothorax set was uncoiling.The wire guide was not manipulated or withdrawn through the needle.The physician felt a snap while withdrawing the wire through the catheter after the needle had already been withdrawn.The patient did not experience any adverse effects nor require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), specifications, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be completed.However, 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 device history record (dhr) for the device and subassembly lots found one related non-conformance for offset coil.There are 100% inspections in place to identify this before shipping, and all nonconforming material was scrapped.It should be noted that there were no other complaints associated with the final product lot number.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.¿ evidence provided upon review of the dmr, product labeling, and dhr does not indicate the 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 product, and the results of our investigation, it was concluded that component failure without any design or manufacturing issue contributed to the incident.It is possible the wire guide became damaged or stuck after the catheters loop was formed, but cook is unable to confirm this.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Common Device Name: 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: 18043865
• Report Number: 1820334-2023-01489
• Device Sequence Number: 7465398
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)240918(10)14973769
• 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): 02/15/2024

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: 09/18/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 14973769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 01/31/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/08/2023; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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