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 Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: administrator/supervisor.Pma/510(k) #: preamendment.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 a (b)(6) year-old male patient required a cope mandril wire guide for a right and left heart catheterization procedure.The wire was difficult to torque through tortuous vein during right brachial vein access.The operator reported the wire "had not torque transmission at the tip on flouro." the access site wire was unraveled and the thin monofilament stayed visible.The user attempted to remove it by threading over a 3 fr cannula but could not.The wire broke off in the patient.The vascular surgeon was called to do a "cut down" however was unable to be removed during the procedure, resulting in 2 cm of the wire remaining in the right arm subcutaneous tissue.The next day, the wire tip was retrieved.No other adverse effects were reported.
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 unchanged, unknown or unavailable.Investigation ¿ evaluation.It was reported to cook that a cope mandril wire guide was difficult to torque through a tortuous vein.The wire unraveled at the access site and the monofilament was visible under fluoroscopy.The patient also had excess fat tissue and angulated elbow.An attempt to remove the wire with a 3fr cannula was unsuccessful and the wire broke off.The wire was removed the following day.This incident was reported by (b)(6) hospital, in the united states.Further communication with the user facility clarified that the wire was not manipulated through a needle.A review of the complaint history, device labeling, device history record, and quality control were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Therefore, no physical/visual examination or dimensional analysis could be completed.However, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) review on the complaint lot recorded related nonconformances, but all nonconforming devices were appropriately dispositioned and appropriate inspections were performed.Additionally, a database search revealed no additional complaints for the complaint lot from the field.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, therefore it was concluded that there is no evidence that nonconforming product exists in house or in field.The cope mandril wire guide is not supplied with an instructions for use (ifu).However, there is a label attached to the wire guide holder/hoop with an image warning the user not to remove the wire guide through the needle.From the document based review, there is no evidence to indicate the device was manufactured out of specification, or that there are non-conforming devices in house or in the field.Based on the information provided, no inspection of returned product and the results of the investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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.
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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10462630
• Report Number: 1820334-2020-01575
• Device Sequence Number: 847517
• Product Code: DQX
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)250610(10)13197977
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

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: 06/10/2025
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 13197977
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 05/05/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/24/2020; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 124