MAUDE Adverse Event Report: COOK INC TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G07303
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: k171997.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the tip of a torq-flex australian modification mandril wire guide unraveled and sheared off during a pacemaker placement procedure.The tip was retained within the patient's subcutaneous tissue.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Event or Problem Description
No additional information can be requested as there is no identifying information for the hospital provided in the medwatch report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: f2 - mw5100651.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation.An unknown customer (united states) contacted cook on 27apr2021 stating that during a pacemaker placement procedure, the stf-18-60-aust wire guide from lot# 13506409, unraveled and sheared off, with the distal tip being retained in the subcutaneous tissue.A review of the documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures of the product was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no dimensional, visual, or functional verifications could be completed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are process checks during the manufacturing process to catch and prevent product from leaving house that would lead to this failure.A review of the device history record (dhr) for lot 13506409 found one relevant nonconformance for wire guide surface defect.It should be noted that there were no other complaints associated with this lot number.Based on the device failure analysis, device history record, and device master record, there is no indication the device was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Cook also reviewed product labeling.This device is supplied with an instructions for use (ifu) t_mwg_rev0.The warning section of the ifu states the following: this product is a delicate instrument.Avoid forceful angulation.Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape or shear material form the wire guide.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL 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: 11797816
• Report Number: 1820334-2021-01310
• Device Sequence Number: 3142691
• Product Code: DQX
• UDI-Device Identifier: 00827002073036
• UDI-Public: (01)00827002073036(17)251110(10)13506409
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2022

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 Expiration Date: 11/10/2025
• Device Model Number: G07303
• Device Catalogue Number: STF-18-60-AUST
• Device Lot Number: 13506409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 12/22/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 09/10/2021; 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown