MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC RETORGRADE CARDIOPLEGIA CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number RC2014MIBB

Device Problems Inflation Problem (1310); Activation Failure (3270)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Catheter balloon did not fully expand on one side of the catheter during cardiac bypass.

• Brand Name: RETORGRADE CARDIOPLEGIA CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15592525
• MDR Text Key: 301634057
• Report Number: 15592525
• Device Sequence Number: 1
• Product Code: DWF
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RC2014MIBB
• Device Catalogue Number: RC2014MIBB
• Device Lot Number: 2022021180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White