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

Model Number	G56535
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: address: (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 or Problem Description
It was reported to cook that wire guide from a wayne pneumothorax set was unable to be removed from the catheter and unraveled.The patient required placement of a chest tube in the right axillary area for treatment of a pneumothorax.The wire guide was first introduced through the needle.There were no difficulties inserting the wire guide through the needle.After the drain was in place, the wire guide was difficult to remove.It became ''stuck'' and unraveled.The drain, straightening obturator and wire guide were removed.The wire guide and the straightening obturator were removed at the same time.The procedure was completed by using another device.The procedure took longer than expected due to the product failure and obtaining new product.The patient also experienced increased pain during the procedure.
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 unknown, unchanged or unavailable.Investigation ¿ evaluation on (b)(6) 2024, it was reported that the wire guide in a wayne pneumothorax set became unraveled.No difficulties were experienced when inserting the wire guide through the needle.After the drain was in place, the guide was difficult to remove and became stuck and then unraveled.The drain, obturator and guide were then removed together before a new drain was inserted.The patient experienced a longer procedure time and increased pain but was otherwise unimpacted.No other adverse effects were reported for this incident.Reviews of the documentation, including the complaint history, device history record, quality control procedures, instructions for use, as well as visual inspection and functional test of the returned device, were conducted during the investigation.Cook received one used catheter, wire guide, and straightening obturator for evaluation.The wire was still inside the catheter and obturator when received.The wire guide was damaged and started unraveling approximately 63.5cm from the proximal end.No damage was noted to the other returned components.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.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 device history record (dhr) for the device found relevant recorded nonconformances that could have contributed to the reported failure mode.All nonconforming devices were scrapped prior to further processing.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 gathered upon review of device master record, product labeling, device history record, and device failure analysis, 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It¿s possible that the wire guide became damaged after insertion and became stuck in the catheter during withdrawal, but cook is unable to confirm this.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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.

• 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: 19344566
• Report Number: 1820334-2024-00683
• Device Sequence Number: 8791781
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)250327(10)15494772
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 03/27/2025
• Device Model Number: G56535
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 15494772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2023
• 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