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

Model Number D97130F5

Device Problems Defective Component (2292); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

Elderly female in hybrid or for transcatheter aortic valve replacement.Pacing malfunction and wires removed intact."pacing wire may be internally severed.The cable is bent and looks to be broken internally".

• 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: 9719837
• MDR Text Key: 179743443
• Report Number: 9719837
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• 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: 02/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 64