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

Model Number	G08426
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6), g4 - pma/510(k) #: exempt, h3: device evaluation anticipated but not yet begun, awaiting device return.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 included in the neff percutaneous access set unraveled during a percutaneous transhepatic cholangiography procedure in an unknown patient.It was initially reported that the wire guide was "faulty".Additional information provided 05sep2025 clarified that, upon removal of the access wire from the insertion needle, the wire was found to be unraveled.To successfully gain access, four additional wires were used.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The three other unraveled wires are referenced in reports with patient identifiers: (b)(6).
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
Additional information: d9 - date returned to mfg.Investigation ¿ evaluation.It was reported that the wire guide included in the neff percutaneous access set unraveled during a percutaneous transhepatic cholangiography procedure in an unknown patient.It was initially reported that the wire guide was "faulty".Additional information provided 05sep2025 clarified that, upon removal of the access wire from the insertion needle, the wire was found to be unraveled.To successfully gain access, four additional wires were used.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The three other unraveled wires are referenced in reports with patient identifiers: (b)(6).Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), specifications, and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.Cook received one used wire guide lodged in the outer cannula of the dchn needle and one prior to use wire guide.The used device was unraveled, with a weld ball present, and the unraveled portion remained lodged in the dchn needle cannula.Inspection confirmed that the needle¿s inner diameter was within specification.During removal, the inner part of the needle felt gritty, likely due to biomatter.The outer diameter of the unused wire guide was also within specification, as was the measurable portion of the unraveled wire guide.Cook has concluded that the device was manufactured to specification.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 lot and related subassembly lots found that one device did not pass quality control inspections; however, the affected product was scrapped.A complaint history search identified no other events reported for the related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.This product is not supplied with an instructions for use (ifu) pamphlet.The wire guide holder is supplied with an l_scor label attached indicating not to withdraw or manipulate the wire guide through a needle.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has determined this event to be due to a failure to follow instructions.It was reported that the customer was removing the device back through the access needle.The device is supplied with a label indicating not to withdraw or manipulate the device through a 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
• 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: 23041141
• Report Number: 1820334-2025-01136
• Device Sequence Number: 10096144
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)280308(10)16501042
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: G08426
• Device Catalogue Number: NPAS-100-NT
• Device Lot Number: 16501042
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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
• Patient Sex: Unknown