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

Model Number N/A

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

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.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 Description

It was reported that the wire included in a neff percutaneous access set separated in an unknown patient during a percutaneous transhepatic cholangiography and drainage (ptcd) procedure.As the physician removed the 0.018' wire, it was noted that a 3.6cm section of the wire had broken off and was left in the patient between the liver parenchyma and the bile duct.The patient was in poor health with a covid-19 diagnosis, so wire retrieval was not arranged immediately.A surgery was scheduled for the patient in november for removal of a pancreatic tumor.It was decided that the wire would be removed at that time.Additional information regarding patient outcome and event details has been requested but is currently unavailable.

Event Description

In additional information provided on 22nov2022, it was reported that the wire was withdrawn or manipulated through the needle.It was confirmed that the piece of wire was removed from the patient during pancreatic tumor surgery in november.This device is now available for return to cook for investigation.

Manufacturer Narrative

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 Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported by (b)(6), that on 16sep2022 the wire guide in a neff percutaneous access set (rpn: npas-100-rh-nt; lot# ns14742530) separated.The device was required for percutaneous transhepatic cholangiodrainage (ptcd).During the procedure, when the wire guide was removed, a 3.6 cm portion of the device separated.The wire was retained in the patient between the liver parenchyma and bile duct.It was reported that the patient was in ¿poor health¿ and was later diagnosed with covid-19; therefore, the wire was not removed immediately.The patient was scheduled for an additional procedure to remove a pancreatic tumor and it was determined the wire would be removed at that time.Further communication with customer confirmed the wire was successfully removed from the patient.It was also noted that the wire was withdrawn or manipulated through the needle during the procedure.No other adverse events were reported due to this occurrence.Reviews of 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.The product was returned to cook for evaluation.One used device was received (only part of the wire guide).The part of the wire guide that was received was returned stretched and elongated.Due to the state of the wire guide it was not possible to get the outer diameter of the wire guide fragment.Cook was unable to find evidence the product was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and identified process steps that check for non-conforming product and prevent non-conforming product from leaving the house.The dhrs for lot# ns14742530 and all related sub assembly lots were reviewed and recorded no relevant non-conformances or additional complaints.There is no evidence of non-conforming material in house or in the field.This product is not supplied with an instructions for use (ifu) pamphlet.It should be noted that the wire guide is packaged with a tag indicating the device should not be removed through the needle.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the most likely cause for this failure is unintended user error.The customer indicated the wire guide was withdrawn/manipulated through the needle.It is possible that when withdrawing the wire guide back through the needle, the wire caught on the edge of the needle and sheared off the segment of the wire guide.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.

• 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: 15872192
• MDR Text Key: 304417872
• Report Number: 1820334-2022-01775
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)250519(10)NS14742530
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• 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: NS14742530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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 Outcome(s): Required Intervention