MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number S9FC146F7

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

The swan balloon was tested under water prior to being inserted into the body.The balloon was fully intact with no air leaking from it.Once inserted into the body the balloon was inflated and did not hold the air.The catheter was exchanged for a new latex-free balloon occlusion thermodilution catheter.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12335733
• MDR Text Key: 267058674
• Report Number: 12335733
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: S9FC146F7
• Device Catalogue Number: S9FC146F7
• Device Lot Number: 63783436
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA