MAUDE Adverse Event Report: MEDTRONIC, INC. SITESEER¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	06SR050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Guided cath became kinked during case: patient was having a cardiac catheterization.When the physician was using a pressure wire, the wire became stuck in the guide catheter.The entire system was removed.The catheter was found to have a kink approx 30cm from the distal end.A new guide catheter and pressure wire was inserted.The case was completed.There was no harm to the patient.There was another cath that had the same issue but was not used in patient.The issue was felt by the provider prior to procedure.No harm.

• Brand Name: SITESEER¿
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne mvs46; moundsview MN 55112
• MDR Report Key: 14309686
• Report Number: 14309686
• Device Sequence Number: 5313820
• Product Code: DQO
• UDI-Device Identifier: 00613994943484
• UDI-Public: (01)00613994943484
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/25/2022
• Report Date (Section F): 04/25/2022

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 Model Number: 06SR050
• Device Lot Number: 0010612573
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 04/25/2022