MAUDE Adverse Event Report: COOK INC STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G02274
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a straight fixed core wire guide separated.During a parotid duct sialoendoscopy, the distal tip of the wire broke in the patient's parotid duct.The physician attempted to retrieve the fragment using graspers from the hospital's set; however, the fragment was too far back in duct for the 1.3 scope.A smaller 1.1 scope was used in order to gain visualization, but the separated portion of the wire was still unable to be retrieved.A scan will be scheduled to determine if the fragment will be retrieved via incision at a later date.The operation time was prolonged as a result of this event.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 ¿ pma/510(k) #: k171764 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.
Additional 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 or Problem Description
In additional information received on 09may2024, it was confirmed that the separated portion of wire will be removed from the patient via incision.The patient is currently being scheduled for the procedure.The device is unable to be returned for evaluation, as it was thrown away by the facility.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that a straight fixed core wire guide separated.During a parotid duct sialendoscopy, the distal tip of the wire broke in the patient's parotid duct.The physician attempted to retrieve the fragment using graspers from the hospital's set; however, the fragment was too far back in duct for the 1.3 scope.A smaller 1.1 scope was used in order to gain visualization, but the separated portion of the wire was still unable to be retrieved.A scan will be scheduled to determine if the fragment will be retrieved via incision at a later date.It was confirmed that the separated portion of wire will be removed from the patient via incision.The patient is currently being scheduled for the procedure.No other adverse effects were reported for this incident.Reviews of the documentation, including the complaint history, device history record, quality control procedures, manufacturing instructions and instructions for use (ifu), as well as visual inspection of the returned product, were conducted during the investigation.There were fifteen unused/sealed wire guides that were returned.All wire guides were opened and inspected.No damage was noted to any of the devices.The complaint device was not returned.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 device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the instructions for use (ifu) t_fcwg_rev2 supplied with the complaint lot were reviewed for the information related to reported failure mode.Per the ifu: ¿warnings: avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape or shear material from the wire guide.¿ evidence gathered upon review of the dmr, dhr, product ifu, and device failure analysis, there is no indication that the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.If the wire guide was withdrawn through the working channel of the scope, it is possible the wire became damaged by the scope.However, this possibility cannot be confirmed without additional information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: STRAIGHT FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, 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: 19233556
• Report Number: 1820334-2024-00597
• Device Sequence Number: 17606118
• Product Code: DQX
• UDI-Device Identifier: 00827002022744
• UDI-Public: (01)00827002022744(17)280920(10)15665969
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G02274
• Device Catalogue Number: C-SF-15-50
• Device Lot Number: 15665969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 10/07/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/15/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: ADVANCE SALIVARY BALLOON.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown