MAUDE Adverse Event Report: MEDTRONIC VASCULAR COUGAR XT STRL 190CM; WIRE, GUIDE, CATHETER

Model Number	CGRXT190HS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing an acute mi intervention, once the stent was placed upon wire removal it seemed to have caught on the stent strut and sheered wire apart.A second stent was placed to oppose wire to vessel wall.Fda safety report id# (b)(4).

• Brand Name: COUGAR XT STRL 190CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 11343683
• Report Number: MW5099464
• Device Sequence Number: 2590720
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: (01)00643169453326
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: CGRXT190HS
• Device Lot Number: G20A6886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2021
• 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: Required Intervention
• Patient Weight: 104