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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: clinical practice manager.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.
Event or Problem Description
It was reported that the wire guide of a wayne pneumothorax tray "came out [the] side of [the] catheter".Photos provided depict an unraveled wire guide.The device was inserted "according to how it's supposed to be." the issue occurred as the user withdrew the obturator and wire guide following catheter placement.Resistance was met and the wire guide unraveled.The needle had been withdrawn over the wire prior to insertion of the dilator.This event occurred during initial device placement.The device was completely removed from the patient and another similar device was used to complete the intended procedure.The patient did not experience any adverse effects as a result of this event.
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
D10 ¿ concomitant medical product received on: 29apr2021.Investigation ¿ evaluation.(b)(6) hospital (united states) contacted cook stating that during removal of the guidewire and obturator from a c-utpty-1400-wayne-112497-imh (lot# 13750069), resistance was met.The wire unraveled and came out the side of the catheter.Cook became aware of this event on (b)(6) 2021.No part of the device was left in the patient.A new set was used to perform the procedure.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.One used catheter was received with the wire through the catheter lumen.The wire was broken and unraveled.A section of the wire coil cut through the catheter material at the proximal end.Cook reviewed the device history record for lot# 13750069.Lot# 13750069 has no relevant non-conformances.Cook reviewed the lot numbers for the scf-38-70-3 wire guide for this set and there are no relevant non-conformances.There are no additional complaints and there are no non-conforming materials in house or in the field.Cook reviewed the design history record and the risks associated with this device were acceptable when weighed against the benefits.Cook reviewed the instructions for use (ifu) for the device.The ifu states the right point to which wire guide and obturator are to be removed: section 9 says remove the wire guide and obturator.The ifu, under section, how supplied, also states that upon removal from package to inspect the product to ensure no damage has occurred.Based on the device failure analysis, device history record, and device master record, there is no indication the device was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Based on the information provided, inspection of returned product and the results of the investigation, it was determined the most likely cause of this event is component failure.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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 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: 11726705
• Report Number: 1820334-2021-01220
• Device Sequence Number: 14280033
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)220201(10)13750069
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 13750069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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