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

Model Number N/A

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

It was reported the wire guide of a neff percutaneous access set broke during a biliary drainage procedure.The user attempted to advance the wire through the needle to access the bile duct; however, difficulty was experienced.After several attempts, the wire guide broke and was unable to be used.The access set was then replaced, and the procedure was performed without any issues.It was noted that the patient did not have tortuous anatomy.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Initial reporter name and address: customer (person): phone : (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 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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.A representative of elemar international forwarding (brazil) contacted cook on (b)(6) 2023 concerning a neff percutaneous access set (rpn: npas-100-rh-nt, lot# 14870401).The customer stated that during a biliary drainage of the abdomen on 28dec2022, difficulty was experienced while advancing the wire guide through the needle.After a few attempts, the wire guide broke.The device was replaced with a new one and the procedure was completed successfully.No part of the product remained within the patient.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, ifu, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure this nonconformance does not leave the house.A review of the device history record (dhr) for the final product lot did not find any relevant nonconformances.There were five relevant nonconformances identified in related subassemblies, in which all nonconforming product was scrapped prior to further processing and the rest was 100% inspected per quality control.It should be noted that there were no other complaints associated with the final product lot number.This product is not supplied with an instructions for use (ifu) pamphlet.The wire guide holder has a label attached (l_scor) indicating to not manipulate or withdraw a wire guide through the needle.Evidence gathered from a review of the dmr and dhr suggests that the device was not manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, it was concluded that a failure to follow instructions contributed to the reported event.The wire guide is equipped with labeling instructing to not manipulate or withdraw the wire guide through the needle, as doing so could lead to wire guide damage.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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: NEFF PERCUTANEOUS ACCESS SET
• Type of Device: 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: 16598552
• MDR Text Key: 312319689
• Report Number: 1820334-2023-00306
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)250801(10)14870401
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 14870401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male