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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that the sheath in a neff percutaneous access set separated at the hub.The device was required for a percutaneous transhepatic cholangiography (ptc) procedure and was advanced into the patient.The sheath and a wire were in place.When the wire was removed, the white hub separated from the black sheath, and the black component was retained in the patient.However, all components were retrieved.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): postal code: (b)(6).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, 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.

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 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

Additional information was received on 16nov2022 from the customer.The case was discussed with the interventional radiologist (ir) consultant that performed the procedure.The ir consultant recalls the case as being fairly difficult, but does not recall any specific issues advancing the device itself.The procedure was completed by using another device of the same type.The ir consultant does not recall any specific details on how the separated component was removed from the patient.No components were left in the patient and the procedure was completed as planned.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported by morriston hospital (great britain) that the sheath in a neff percutaneous access set (rpn: npas-100-nt; lot#: 14713430) separated at the hub.The device was required for a percutaneous transhepatic cholangiography (ptc) procedure.The device was placed in the patient with a wire.When the wire was removed, the hub of the sheath separated, and the shaft was retained in the patient.All components were then removed from the patient.Further communication with the physician indicated the case was ¿fairly difficult¿, but the physician did not note any issues when advancing the device.The physician could not recall specific details regarding removal of the separated sheath.No other adverse effects were reported due to this event.In this event, patient harm occurred as the patient required surgical intervention to remove the separated sheath from the patient.Reviews of the documentation, including the complaint history, device history record, quality control procedures and specifications, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used device was returned for evaluation.The sheath had some kinks and was found to be separated from the hub.The hub had no sheath material in it.Dimensional verification of the sheath found the inner and outer diameter to be within specification.The flare was found to be out of shape; however, it is possible that the flare shape seen in the lab could have been caused when the flare and hub separated.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that the sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14713430 found no nonconformances that could have contributed to the reported failure mode.Component lot ic14585777 had one nonconformance, in which one device was scrapped for a surface defect.Component lot ic14585764 had nonconformances for shaft damage (qty 5) and an inadequate flare (qty 1), in which all nonconforming devices were scrapped.It should be noted that there were no other complaints associated with the final product lot number.Evidence gathered upon review of the dmr, the dhr, and the device failure analysis, suggest that there is no evidence of non-conforming material in house or in the field.Cook was not able to determine the product was manufactured out of specification.This product is not supplied with an instruction for use (ifu) pamphlet.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure contributed to the event.Per discussion with production and engineering, the flare is out of shape, which would lead to this failure.However, per same discussion, it is possible that the flare shape seen in lab could have been caused when the flare and hub separated.With this it cannot be determined that this failure was due to the flare being manufactured out of specification.It is also possible that procedural events contributed to this occurrence; however, this cannot be confirmed without additional information.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: 15632469
• MDR Text Key: 302005002
• Report Number: 1820334-2022-01644
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)250506(10)14713430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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-NT
• Device Lot Number: 14713430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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
• Patient Outcome(s): Required Intervention