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

Model Number 06SR050

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Event 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¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne mvs46; moundsview MN 55112
• MDR Report Key: 14309686
• MDR Text Key: 290930731
• Report Number: 14309686
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00613994943484
• UDI-Public: (01)00613994943484
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06SR050
• Device Lot Number: 0010612573
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male