MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC CORDIS; INTRODUCER, CATHETER

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/16/2022

Event Type  malfunction  

Event Description

Cordis was leaking near the insertion site.

• Brand Name: CORDIS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15128612
• MDR Text Key: 296865299
• Report Number: 15128612
• Device Sequence Number: 1
• Product Code: DYB
• 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: 07/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1