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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

It was reported that an 80 year-old male patient required snare retrieval for a separated portion of a wire guide in a neff percutaneous access set.The neff percutaneous access set was being used to access the patient's kidney.Once the chiba needle was in place, the inner stylet was removed, and the.018 wire was advanced with no difficulties or resistance.When the wire was pulled back, the tip of the wire was no longer attached to the body of the wire.The tip of the wire was retrieved within the same procedure with a snare kit.The procedure was then completed, and the nephrostomy tube was successfully inserted.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 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 unknown, unavailable, or unchanged.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 the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) hospital (untied states) informed cook on 08may2023 of an issue with a neff percutaneous access set (rpn: (b)(4); lot 14541887).The customer stated that once the needle was in place, the inner stylet was removed, and the.018 wire guide was advanced with no difficulty or resistance.When the wire guide was pulled back, the tip of the wire guide was no longer attached to the wire guide.The tip of the wire was retrieved from the patient with a snare kit.No adverse effects have been reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and manufacturing instructions (mi), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used wire guide was returned to cook for evaluation.Upon visual inspection, the wire guide separated at 53.5 cm.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 14541887 and the related subassembly lots revealed no relevant non-conformances.Based on the device master record, device history record, and device evaluation, there is no indication the complaint device was manufactured out of specification.Since there are no additional complaints or relevant nonconformances, there is no evidence that nonconforming material exists in house or in the field.This device is not currently packaged with instructions for use.The wire guide holder has an l_scor_rev.0 caution label attached to it that provides illustration to not remove the wire guide through the needle.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be failure to follow instructions.As reported, the needle was in place, and the wire guide was advanced without difficulty or resistance.When the wire was pulled back, the tip of the wire guide separated.The wire guide holder has a label that illustrates to not remove the wire guide through the needle.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: 16956379
• MDR Text Key: 315503927
• Report Number: 1820334-2023-00626
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002042674
• UDI-Public: (01)00827002042674(17)250216(10)14541887
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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
• Device Lot Number: 14541887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male