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

Model Number TS105F5

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Event Description

Swan 5fr would not give wave forms for cardiac output but would do pressures; same issue with 2 catheters.Product had patient contact but no patient harm.Both failures available for pick up.Manufacturer response for cath thermo j-tip 5fr 105cm, (brand not provided) (per site reporter).Waiting for rep to pick up product for evaluation.

• Brand Name: SWAN-GANZ TRUE SIZE
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8531167
• MDR Text Key: 142507239
• Report Number: 8531167
• Device Sequence Number: 1
• Product Code: DYG
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 61508284/6137811
• 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: 03/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA