MAUDE Adverse Event Report: COOK INC COPE MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): postal code: (b)(6) phone: (b)(6).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.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.
Event or Problem Description
It was reported that a cope mandril wire guide separated.During a peritoneal dialysis procedure, the wire guide was placed in the patient's abdomen via micropuncture access.When the wire guide was removed, it unraveled, and a portion was retained in the patient.The wire guide was then retrieved from the patient under imaging.No other adverse effects were reported for this incident.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported by a representative of barwon health hospital (australia) that on (b)(6) 2023 a cope mandril wire guide (rpn: pmg-18sp-60-cope; lot#: 14484648) unraveled.The device was required for a peritoneal dialysis catheter placement procedure.During removal of the wire guide from the ¿micropuncture access¿, the wire unraveled, and a portion of the wire remained in the patient.The wire fragment required removal with image guidance.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control 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.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 dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu [ t_mwg_rev0] supplied with the device states the following in consideration of the reported failure mode: warnings: "this 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 from the wire guide." precautions: "when you use the wire guide with another device, consider the end-hole size and the length of the device in order to ensure a proper fit between the wire guide and the device." how supplied : "upon removal from package, inspect the product to ensure no damage has occurred." based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.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: COPE 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: 17107931
• Report Number: 1820334-2023-00714
• Device Sequence Number: 6273541
• Product Code: DQX
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)270128(10)14484648
• 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,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 14484648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: 5 FR MICROPUNCTURE SET, MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 93 KG