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

Model Number	PX260
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
As reported, during use in patient this pressure monitoring set displayed inaccurate values.The data displayed differed greatly from the expected values according to the patient's conditions.There was no comparative data obtained from another source.Replacing the sensor with a new one solved the issue.There was no allegation of patient injury.The device is expected to be received for evaluation.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Updated section h6 (device code, type of investigation, investigation findings and investigation conclusions).Customer report of "inaccurate values" was unable to be confirmed.The dpt (disposable pressure transducer) zeroed and sensed pressure accurately on pressure monitor.Pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input and output impedances were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the sensor during pressure test.No visible damage was observed from the sensor.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.There are internal controls during the manufacturing process to avoid potential causes related to the reported malfunction, such as flow, leak, voltage test and electrical test.All events will continue to be reviewed and monitored.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23820701
• Report Number: 2015691-2025-10249
• Device Sequence Number: 18465375
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)260927(11)240927(10)66010551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Model Number: PX260
• Device Lot Number: 66010551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown