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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during implantation, while placing the chest tube, the guidewire of a wayne pneumothorax tray unraveled.The guidewire was able to be retrieved entirely.The chest tube was reinserted.No adverse effects to the patient have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that a wire guide from a wayne pneumothorax tray (c-utpty-1400-wayne-112497-imh) from lot 13433907 unraveled during a chest tube procedure.The wire guide was able to be retrieved entirely, but the chest tube required reinsertion.Cook became aware of this event on (b)(6) 2020 upon being notified by east texas medical center.The patient status is unknown.Additional information regarding the procedure and the patient was requested but not provided.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device were conducted during the investigation.The complaint device was not returned for evaluation; however, a photo of the complaint device was provided by the customer.The safety wire appears broken a few centimeters prior to the distal end.There is also extreme coil elongation.The safety wire breaking is likely what led to the coil unraveling.Cook has concluded that the device was manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record and a database search revealed no nonconformances or additional complaints associated with this failure mode.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: "instructions for use: 3.Insert the introducer needle through the incision into the pleural cavity.4.When the needle tip enters the pleural cavity, introduce the flexible end of the wire guide into the needle 10-15 cm.5.Remove the needle, leaving wire guide in place.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the provided images, and the results of the investigation, a definitive root cause for the unraveling was traced to component failure unrelated to a manufacturing or design deficiency.It is possible that the wire guide was damaged upon advancement through the sharp end of the needle, but no additional procedural information was provided so this cannot be confirmed.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.
Event or Problem Description
No additional patient/event information 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
• MDR Report Key: 10794440
• Report Number: 1820334-2020-02021
• Device Sequence Number: 1137873
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)211001(10)13433907
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 13433907
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1