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

Model Number	N/A
Medical Device Problem Codes	Unraveled Material (1664); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone : (b)(6) , email : (b)(6).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 the wire guide of a neff percutaneous access set unraveled during a biliary drainage procedure in the abdomen of a 67 year-old, female patient.After the bile duct was punctured, the user experienced great difficulty in passing the wire guide through the needle.After a few attempts, the wire guide ended up "fraying" which made it impossible to use it again.Therefore, the device was immediately replaced by another like device and the procedure was conducted normally without any other occurrences.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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
Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of (b)(6) 2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on (b)(6) 2023.Per (b)(4), questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: "¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational." an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.Investigation ¿ evaluation.It was reported the wire guide of a neff percutaneous access set unraveled during a biliary drainage procedure.After the bile duct was punctured, difficulty was experienced advancing the wire guide through the needle.After a few attempts, the wire guide unraveled and could not be used again.Therefore, the device was immediately replaced by another like device and the procedure was conducted normally without any other occurrences.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), and quality control procedures of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 complaint device lot and the related subassembly lots revealed no relevant non-conformances.A complaint history search revealed there are no other complaints on this reported lot.Based on the dmr, the dhr and no product return, cook was not able to find evidence the product was manufactured out of specification.There is no evidence of nonconforming product in house or in the field.Cook also reviewed product labeling.The wire guide holder supplied with the complaint device is equipped with a label (l_scor) indicating to not withdraw or manipulate the wire guide through a needle.Based on the information provided, no product returned, and the results of the investigation, the cause for this event was concluded to be unintentional user error.As reported, the wire guide was attempted to be advanced a few times through the needle which suggests that the wire guide was manipulated inside the 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: 17454634
• Report Number: 1820334-2023-01016
• Device Sequence Number: 7416130
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)250620(10)14803212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 06/20/2025
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 14803212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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 DAWSON MUELLER DRAINAGE CATHETER.; COOK HYDROPHILIC GUIDE WIRE, RPC-35-145.; KMP ANGIOGRAPHIC CATHETER.
• Patient Age: 67 YR
• Patient Sex: Female