MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PX260
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At least 3 separate incidents have occurred involving arterial line pressure monitoring tubing.Specifically, the blue rubber "pig tail" has broken off when flushing and or zeroing a patient's arterial line.No excessive force was used in any of these occurrences where pig tail has broken off.Manufacturer response for transducer, pressure, catheter tip, truwave (per site reporter).
Event or Problem Description
At least 3 separate incidents have occurred involving arterial line pressure monitoring tubing.Specifically, the blue rubber "pig tail" has broken off when flushing and or zeroing a patient's arterial line.No excessive force was used in any of these occurrences where pig tail has broken off.Manufacturer response for transducer, pressure, catheter tip, truwave (per site reporter).N/a.

• Brand Name: TRUWAVE
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 21813481
• Report Number: 21813481
• Device Sequence Number: 8974130
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025
• Report Date (Section F): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 65955827
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/10/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/07/2025