MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP; CATHETER, PERCUTANEOUS

Model Number	67005200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 50¿s male with recent fever, chest pain and non-st-segment elevation myocardial infarction.Taken for emergent heart cath and percutaneous coronary intervention of left anterior descending (lad).Problem with the guide cath, it could not be transduced; as if it were occluded.Device removed and a new one used without difficulty.No known harm to patient.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 12868424
• Report Number: 12868424
• Device Sequence Number: 3607858
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: (01)20705032020142(17)240831(10)18056637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/15/2021
• Report Date (Section F): 11/15/2021

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 Model Number: 67005200
• Device Catalogue Number: 67005200
• Device Lot Number: 18056637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 116 KG
• Date Report Sent to FDA: 11/15/2021