MAUDE Adverse Event Report: COOK INC NEFF PERCUTANEOUS ACCESS SET; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the wire guide of a neff percutaneous access set unraveled prior to use during a transjugular intrahepatic portosystemic shunt (tips) procedure in the biliary tract of an unknown patient.Upon opening the package of the device, the wire guide was noticed to be unraveled.The procedure was completed by using another new device.As reported, the patient had no contact with the device and did not experience any adverse effects or require any additional procedures.
Additional Manufacturer Narrative
Customer (person): address: (b)(6).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.
Additional Manufacturer Narrative
Investigation-evaluation on 15jun2023, sinopharm group med-tech company, ltd.Located in (b)(6) reported to cook that on 14jun2023, upon opening a neff percutaneous access set (rpn: npas-100-rh-nt, lot 14789063), the wire guide was noticed to be unraveled.The discovery was made prior to patient contact.The procedure was completed using a new device.The patient had no contact with the device and did not experience any adverse effects or require any additional procedures.Reviews of documentation including the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned device were conducted during the investigation.One prior to use wire guide was returned to cook for evaluation.Upon visual inspection of the device, it was noted that the wire guide was unraveled.The unraveling was noted to begin 7 cm from the distal tip of the device.The welds of the wire guide were found to be intact per visual examination.A slight bend was noticed near the distal tip of the wire guide.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 dhrs for the reported complaint device lot (14789063) and the related subassembly lots revealed two related non-conformances.All nonconforming product was scrapped, and all remaining product in these lots were 100% inspected per quality control.The information provided upon review of the dmr, dhr, and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.This product is not supplied with an instructions for use (ifu) pamphlet.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause had ben traced to transport damage.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• 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: 17143588
• Report Number: 1820334-2023-00767
• Device Sequence Number: 7690112
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)250613(10)14789063
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 06/13/2025
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 14789063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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