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

Model Number	G10797
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3- occupation: pharmacy.G4 - 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 or Problem Description
It was reported that the wire guide from a neff percutaneous access set separated.The device was required for a percutaneous biliary drainage procedure with two biliary prostheses performed in interventional radiology.During the procedure, as the wire guide was removed from the chiba needle, the wire caught the tip of the needle and subsequently unraveled and broke.A portion of the wire guide was retained in the patient's liver.There was no immediate clinical consequence reported, and patient monitoring is planned.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Additional information: a2.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.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 or Problem Description
Additional information was provided 22oct2024.The tip of the wire guide will remain in the patient.There are no plans to remove the wire guide fragment.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported that the wire guide from a neff percutaneous access set separated.The device was required for a percutaneous biliary drainage procedure with two biliary prostheses performed in interventional radiology.During the procedure, as the wire guide was removed from the chiba needle, the wire caught the tip of the needle and subsequently unraveled and broke.A portion of the wire guide was retained in the patient's liver.The tip of the wire guide will remain in the patient.There are no plans to remove the wire guide fragment.There was no immediate clinical consequence reported, and patient monitoring is planned.No other adverse effects were reported for this incident.Reviews of the documentation, including the complaint history, device history record, drawing, quality control procedures and specifications 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 sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review the device labeling, as an ifu pamphlet is not included with the complaint device.The wire guide holder is supplied with an l_scor label attached indicating to not withdraw or manipulate the wire guide through the needle.Evidence gathered upon review of the dmr, dhr and attached labeling, cook was not able to find evidence suggesting the product was manufactured out of specification.Cook was not able to find evidence of nonconforming product in house or in the field.Based on the information provided, no product returned, and the results of our investigation, it was concluded that this event to be due to a failure to follow instructions.The customer stated that they attempted to withdraw the wire guide out of the needle when it became damaged.The wire guide holder has a label attached indicating to not withdraw or manipulate the wire guide through the needle.Per the risk assessment no further action is required.The appropriate personnel have been notified.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 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: 20152834
• Report Number: 1820334-2024-01179
• Device Sequence Number: 8397121
• Product Code: KGZ
• UDI-Device Identifier: 00827002107977
• UDI-Public: (01)00827002107977(17)270610(10)16100311
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G10797
• Device Catalogue Number: NPAS-105-RH-NT-U
• Device Lot Number: 16100311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 10/22/2024; 11/26/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/16/2024; 10/24/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Unknown