MAUDE Adverse Event Report: MEDTRONIC, INC. COUGAR GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	CGRXT190HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Vascular Dissection (3160); Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a crt implantation procedure the patient suffered a tamponade from a perforation in the non-tortuous, no n-calcified coronary sinus (cs).The lesion was not pre-dilated.Resistance was not encountered when advancing the device.Excessive force was not used.The rv lead and ra lead were successfully positioned.All measurements were within the normal range.The cs cat heter was flushed and adequately prepared.A 0.035" non-medtronic wire, a 6250vi-mp catheter and an al1, 6f guiding catheter were advanced to the cs.The cs was probed with the wire and the al1, and the 6250vi-mp catheter was introduced over the wire.Contrast medium was injected to confirm the positioning.The 6215 balloon catheter was then introduced to visualize the cs.The 6215 balloon catheter was flushed and advanced using a cougar xt guidewire over the existing cs catheter.The cougar guidewire was inspected before use and prepped per ifu with no issues.The wire tip was not formed by the physician.After advancing the 6215 balloon catheter, the cougar xt guidewire was removed, and the 6215 balloon was inflated after positioning was confirmed with contrast medium.A cs visualization was performed in anterior-posterior (ap) and repeated in left anterior oblique (lao).The patient then complained of chest discomfort, and an echocardiogram was immediately performed.A significant drop in blood pressure was observed and a tamponade was detected.The patient suffered an intraoperative dissection of the cs.The heart team and reanimation (rea) took over the procedure.Surgical and medical intervention was required.The tamponade was treated with pericardial puncture.The physician did not assess that the tamponade event was directly related to the use of the cougar guidewire device.The patient is currently in the intensive care unit.
Additional Manufacturer Narrative
Additional information: annex d code.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: COUGAR GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21372280
• Report Number: 2182208-2025-00695
• Device Sequence Number: 3758802
• Product Code: DQX
• UDI-Device Identifier: 00763000570132
• UDI-Public: 00763000570132
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CGRXT190HS
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G23A10815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/15/2025
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown