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

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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.

Event Description

It was reported an unknown patient required a neff percutaneous access set for a percutaneous transhepatic biliary drain & percutaneous nephrostomy procedure.During the procedure, the operator noticed the wire "cannot be pulled back" into the needle.As reported, the needle "injures the wire and makes it stick to the tip." this occurred with a total of five devices from the same lot.The "whole system" was removed and the device was replaced with a new, similar device to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: b3, h6-device code.B3 - event date cannot be confirmed, but the event occurred sometime in the first ten days of (b)(6) 2019.H6 - additional methods code: communication/interviews (4111).Investigation ¿ evaluation.(b)(6) from united medical industries informed cook of an incident involving a neff percutaneous access set in the first ten days of (b)(6) 2019 during a procedure to gain access.Once the wire was advanced through the needle, the wire could not be pulled back through the needle.The needle injured the wire and caused the wire to stick to the tip.The physician was forced to pull whole system from the patient and lose access.This occurred with two devices of the same lot on this patient.No unintended section of the device remained inside the patient¿s body and the patient did not require additional procedures due to this occurrence.A review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and specifications of the 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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion the tensile test peak loads exceeded the requirement.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed no related nonconformances.A database search was completed on the complaint lot and three additional complaints were found.These complaints were reported from the same user facility for the same failure.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no related non-conformances, and a user error contributed to this failure, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of the product¿s instructions for use [ifu] could not be reviewed because no ifu exists for the neff percutaneous access set.However, the wire guide holder comes with a caution label.This label depicts a warning to the user to not remove the wire guide proximally through a needle.Based on the information provided to cook, the device was used in a manner that is inconsistent with the product labelling.Specifically, the wire guide was withdrawn through the needle.Cook recommends against this action as withdrawing the wire guide through a needle may contribute to the wire guide breaking.A warning label is provided which cautions against this.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.Based on the information provided, no returned product and the results of the investigation, the cause was traced to the user due to failure to follow instructions.A customer letter will be sent to the customer informing them the device was used in manner that is inconsistent with product labeling.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.

Event Description

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

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

Additional information received 18dec2019: in this complaint only two devices were reported used.It was originally reported five total devices were used.The three other devices mentioned were used on different patients/procedures.One (1) each of the remaining 3 devices mentioned in the initial report will be captured in the following reports: medwatch report #1820334-2020-00012, medwatch report # 1820334-2020-00013, medwatch report # 1820334-2020-00014.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9465485
• MDR Text Key: 175850882
• Report Number: 1820334-2019-03103
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)220307(10)9576668
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 9576668
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1