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

Model Number	G10544
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 guidewire included in the neff percutaneous access set unraveled and was not able to use.The procedure was completed by using another new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
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
In additional information received on (b)(6) 2024, it was confirmed that the wire guide was not manipulated or withdrawn through the needle.The complaint device did not make patient contact.
Additional Manufacturer Narrative
Correction: h6- annex a investigation ¿ evaluation it was reported that the guidewire included in the neff percutaneous access set unraveled and was not able to use.The procedure was completed by using another new device.It was confirmed that the wire guide was not manipulated or withdrawn through the needle.The complaint device did not make patient contact.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, quality control procedures, manufacturing instructions, drawing and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One prior to use wire guide and dchn needle were received for evaluation.The junction point approximately 6.5cm from the distal tip of the coil began to unravel.The part of the wire guide that separated was not returned.Additionally, 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.Three associated subassembly lots for wire guides were also reviewed.One relevant nonconformance was found for the first wire guide lot, and another in the second; in which all the nonconforming devices were scrapped.The third wire guide lot showed no nonconformances.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.Evidence gathered upon review of the dmr, dhr and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could not be established.For the damage like this to occur, force would have had to be applied to the wire guide.It is possible that this could have occurred during transport of the product and was not noticed until the customer attempted to use the device.Although it was stated that the wire guide was not manipulated or withdrawn through the needle, if enough force was applied to the wire guide when attempting to advance through the needle, it is a possibility this could have been enough to damage the wire in this manner.It is possible that the device was out of specification; however, with the solder end missing this cannot be confirmed.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: 20641496
• Report Number: 1820334-2024-01469
• Device Sequence Number: 7367230
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)270716(10)16158194
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/30/2025

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: 16158194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 06/03/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/14/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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
• Patient Sex: Unknown