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

Model Number N/A

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/15/2023

Event Type  Injury  

Event Description

It was reported, that the wire guide included in the neff percutaneous access set unraveled.And separated during a liver transcutaneous cholangiography procedure on a 76-year-old male patient.It was noted, that the wire guide "behaved differently than usual", during insertion into the bile duct.The wire and needle were removed from the patient as a unit.Upon removal from the patient, it was found that the wire had unraveled and separated.Leaving an unintended portion of the wire inside of the patient.The physician, then opened an unknown cope wire to continue the procedure.But found that it also behaved differently, and reported that it had been "bitten" by the needle.A second npas kit was opened to obtain the wire, that was used to complete the procedure successfully.It is currently, unknown if the portion of separated wire will be retrieved from the patient.Additional information regarding event and device details have been requested, but are currently unavailable.

Manufacturer Narrative

E1 - customer (person): phone : (b)(6), additional phone: (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.

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 Description

In additional information received on 27jun2023, it was reported that there are no plans to retrieve the portion of separated wire guide from the body of the patient.The separated portion of the wire guide was a part of the wire guide provided in the neff percutaneous access set.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 Description

Additional information was provided on (b)(6) 2023.The wire was manipulated through the needle that was provided with the cook neff percutaneous access set.The distal end of the the wire that was provided in the cook neff percutaneous access set remained inside the patient and could not be removed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: the customer stated that during a liver transcutaneous cholangiography procedure on (b)(6) 2023, the wire guide included in this set was behaving differently than usual.When the customer attempted to remove the wire guide, the device separated, leaving a portion of the device in the patient.The wire guide and needle were then removed together.The customer then opened and used another cope wire guide to replace the damaged one.However, the customer stated that this wire guide became caught by the needle.The customer feels that the needle was the problem.The customer stated both wire guides were manipulated through the same needle from the complaint set.The patient did not require any additional procedures or experience any adverse effects 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) identified process steps to ensure nonconforming product does not leave the house.A review of the device history record (dhr) for the final product and subassembly lots found relevant nonconformances, in which all nonconforming products were scrapped, and the rest 100% inspected per quality control.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review product labeling.This product is not supplied with an instructions for use (ifu) pamphlet.The wire guide is supplied with an l_scor label indicating to not manipulate or withdraw the wire guide through a needle.Evidence provided upon a review of the dmr, 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 products in house or in the field.Based on the information provided, no returned product, and the results of our investigation, it was concluded that an unintended user error likely contributed to the reported event.The customer stated that the wire guide was attempted to be withdrawn through the needle.A label attached to the wire guide indicates not to withdraw or manipulate the wire guide through the needle.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Type of Device: 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: 17194912
• MDR Text Key: 317809974
• Report Number: 1820334-2023-00810
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)251025(10)15037454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 15037454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PMG-18SP-60-COPE-NT-ST, LOT: 13559703; UNKNOWN COPE WIRE
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male