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

Model Number 67027000

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Catheter was discovered kinked when pulled out of the packaging, prior to the procedure.New guiding catheter was opened and used for the case.

• Brand Name: VISTA BRITE TIP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 17197882
• MDR Text Key: 317871553
• Report Number: 17197882
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 67027000
• Device Catalogue Number: 67027000
• Device Lot Number: 18159924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male