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	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of abnormal stress test.Procedure: heart cath with percutaneous coronary intervention.Guide packaging was opened, and shaft was kinked.Never removed from original packaging which was stored on a shelf.Not used on patient.Manufacturer response for catheter, percutaneous, vista brite tip (per site reporter) will obtain.

• 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: 14456529
• Report Number: 14456529
• Device Sequence Number: 4569699
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: (01)20705032020142(17)250228(10)18098881
• 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): 05/13/2022
• Report Date (Section F): 05/13/2022

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: 67005200
• Device Catalogue Number: 67005200
• Device Lot Number: 18098881
• 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: 05/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 05/13/2022