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

Model Number	131F7
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10424822
• Report Number: 10424822
• Device Sequence Number: 3025867
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)220401(11)200401(10)63080005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/12/2020
• Report Date (Section F): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 63080005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64
• Date Report Sent to FDA: 08/12/2020