MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, FLOW DIRECTED

Model Number 131F7

Device Problem Inflation Problem (1310)

Patient Problem Complete Heart Block (2627)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Elderly female with history of hypertension and shortness of breath due to aortic stenosis.When having a heart cath, the balloon would not inflate.Patient went into heart block and a temporary pacer was inserted during the procedure.Balloon would not inflate on an edwards swan catheter.This caused the patient to go in to heart block and temporary pacer inserted.Doctor consulted and then had a permanent pacemaker placed a day later.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10424822
• MDR Text Key: 203470080
• Report Number: 10424822
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)220401(11)200401(10)63080005
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 63080005
• 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: 08/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Weight: 64