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

Model Number	G56537
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 guide from a wayne pneumothorax tray elongated and unraveled during a left pleural chest tube and centesis procedure.The wire guide was utilized with a competitor's 8.5 pigtail catheter.During attempted removal of the wire, unraveling was noted.The catheter and wire were removed together as a unit, and the procedure was completed with a new kit and catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
The wire guide was not manipulated or removed through the access needle.It was manipulated or removed through the catheter.
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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported that the wire guide from a wayne pneumothorax tray elongated and unraveled during a left pleural chest tube and centesis procedure.The wire guide was utilized with a competitor's 8.5 pigtail catheter.During attempted removal of the wire, unraveling was noted.The catheter and wire were removed together as a unit, and the procedure was completed with a new kit and catheter.The wire guide was not manipulated or removed through the access needle.It was manipulated or removed through the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures and instructions for use (ifu) of the device, as well as visual inspection of the returned product, were conducted during the investigation.The supplied wire guide was examined, confirming the shaft of the coil was elongated.A detailed examination identified offset coils at approximately 52cm, when measuring from the proximal end.The safety wire and j-tip weld connection separated, resulting in coil elongation and safety wire protrusion.Both weld connections were confirmed to be present, with no evidence of separation from the coils.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 no relevant nonconformances that could have contributed to the reported failure mode.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: how supplied ¿-upon removal from package, inspect the product to ensure no damage has occurred." evidence gathered upon review of the dmr, dhr, ifu and device evaluation suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out 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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• 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: 19819596
• Report Number: 1820334-2024-00998
• Device Sequence Number: 12914695
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)250818(10)15785734
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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: 08/18/2025
• Device Model Number: G56537
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 15785734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 10/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/05/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MERIT 8.5 PIGTAIL CATHETER
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 57 KG