MAUDE Adverse Event Report: COOK INC JEFFREY WIRE GUIDE EXCHANGE SET; KGZ ACCESSORIES, CATHETER

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported the wire guide in a jeffrey wire guide exchange set separated during a percutaneous transhepatic biliary drainage procedure.The wire was advanced into the patient and was navigated around a bend.A competitor's dilator was advanced over the wire and the wire was removed.At this time, a portion of the wire broke and was retained in the bile duct.A safety wire was then advanced to maintain access to the bile duct and the wire fragment was retrieved using a snare.The procedure was completed with a new wire guide.It was noted that the procedure was prolonged due to this incident.No other adverse effects were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: coordinator, supplies & business service.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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation it was reported by a representative of university of colorado hospital (usa) that on 28nov202 the wire guide in a jeffrey wire guide exchange set (rpn: jwge-104-rh-nt; lot#: 13431655) separated during a percutaneous transhepatic biliary drainage procedure.The wire was advanced into the patient and was navigated around a bend.A competitor's dilator (merit coaxial) was advanced over the wire and the wire was removed.At this time, a portion of the wire broke and was retained in the bile duct.A safety wire was then advanced to maintain access to the bile duct and the wire fragment was retrieved using a snare.The procedure was completed with a new wire guide.It was noted that the procedure was prolonged due to this incident.No other adverse effects were reported.Reviews of the complaint history, device history record (dhr), and quality control, as well as a visual inspection of the returned device were conducted during the investigation.One used and damaged wire guide was returned to cook for evaluation.Upon visual inspection, it was noted the distal end of the wire guide was separated from the rest of the wire guide.Cook has concluded that the device was manufactured to specification.Additionally, 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 related non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.There are no instructions for use (ifu) associated with this device.According to council directive 93/42/ec or 14 june 1993 concerning medical devices located in 13.1 subclause (4): instructions for use must be included in the packaging for every device.By way of exception, no such instructions for use are needed for devices in class i or iia if they can be used safely without and such instruction.As the jeffrey wire guide exchange set is a class iia device, it can be used safely without instructions for use when used by a properly trained and experienced physician.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that the wire was damaged by the dilator, or the wire guide was manipulated through the access needle, but this cannot be definitively confirmed.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 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.

• Brand Name: JEFFREY WIRE GUIDE EXCHANGE 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: 15920900
• MDR Text Key: 304872879
• Report Number: 1820334-2022-01810
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002120167
• UDI-Public: (01)00827002120167(17)230915(10)13431655
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: N/A
• Device Catalogue Number: JWGE-104-RH-NT
• Device Lot Number: 13431655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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: COAXIAL DILATOR (MERIT MEDICAL)
• Patient Outcome(s): Required Intervention