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

Model Number 67005200

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 05/12/2022

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 14456529
• MDR Text Key: 292180835
• Report Number: 14456529
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: (01)20705032020142(17)250228(10)18098881
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male
• Patient Weight: 102 KG