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

Model Number	G10460
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In additional information received on 06jun2024, it was reported that the wire was inserted though the needle and withdrawn as a whole set.The patient did have some partially tortuous anatomy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.During a percutaneous transhepatic biliary drain insertion, the intrahepatic duct was punctured with the chiba needle.Then the wire guide was advanced into the intrahepatic duct; however, the wire fractured.Action was taken to immediately retrieve the wire guide.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
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 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
Investigation ¿ evaluation it was reported that the wire guide from a neff percutaneous access set separated.During a percutaneous transhepatic biliary drain insertion, the intrahepatic duct was punctured with the chiba needle.Then the wire guide was advanced into the intrahepatic duct through the needle and withdrawn as a whole set, however, the wire fractured.Action was taken to immediately retrieve the wire guide.The patient did have some partially tortuous anatomy.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.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 one relevant nonconformance that could have contributed to the reported failure mode, in which two devices were scrapped.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.However, the wire guide was supplied with an l_scor label indicating to not withdraw or manipulate the wire guide through the needle.Evidence gathered upon review of upon review of the dmr, dhr and no product return, cook was not able to find evidence that the product was manufactured out of specification.There is no evidence of nonconforming product in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing deficiencies contributed to the reported event.It is possible that if the wire guide was being manipulated in the needle due to patient tortuous anatomy and the wire guide could have become damaged to the point that the device separated.It is possible that the patient¿s tortuous anatomy alone could have led to this event.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.

• 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: 19489941
• Report Number: 1820334-2024-00778
• Device Sequence Number: 7165023
• Product Code: KGZ
• UDI-Device Identifier: 00827002104600
• UDI-Public: (01)00827002104600(17)260524(10)15461233
• 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,Followup
• Report Date (Section B): 10/11/2024

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 Expiration Date: 05/24/2026
• Device Model Number: G10460
• Device Catalogue Number: NPAS-100-RH
• Device Lot Number: 15461233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 10/09/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/13/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown