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

Model Number	G10544
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4- pma/510(k) #: exempt.H3: device evaluation anticipated, but not yet begun.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
It was reported that the wire guide of a cook neff percutaneous access set was difficult to advance and remove.The patient was undergoing an intercostal, ultrasound-guided percutaneous transhepatic intrahepatic bile duct drainage (ptcd) procedure.The patient was placed in a supine position, positioned under ultrasound guidance, and the puncture point was marked.Local anesthesia and regular drape were used.The percutaneous introducer was disassembled.The percutaneous needle was used to insert the needle obliquely for puncture.Next the wire guide was inserted.An attempt was made to advance the wire guide, but resistance was encountered and the wire guide could not be advanced further.It was planned to withdraw the wire guide and try again, but the wire guide was not able to be removed.Another cook neff percutaneous access set (rpn: npas-100-rh-nt) was used to successfully to re puncture and complete the procedure.A photo of the device was provided by the customer for the investigation.The photo showed the wire guide unraveled.The subject of this report is the wire guide that was difficult to advance and difficult to remove and then unraveled.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Correction: 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 on 30jan2026 indicating that the wire guide straightener was not used when advancing the wire guide.The initial date of awareness for the manufacturer was 27jan2026, not 19jan2026 as previously reported.

• 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: 24202309
• Report Number: 1820334-2026-00092
• Device Sequence Number: 5534483
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)281021(10)16836135
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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 Model Number: G10544
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 16836135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 05/19/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/09/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK INC, RPN: NPAS-100-RH-NT.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: Asian