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

Model Number	PX260
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, before using this pressure monitoring set, it was found that the pouch was not sealed and did not meet sterile standards, therefore, it was replaced.No picture is available.There is no allegation of patient injury.Patient demographics were not provided.
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.
Additional Manufacturer Narrative
Corrected sections d7a (single use device reprocessed and reused), e1 (reporter address city and province), g2 (report source, other - china) updated section h6 (component code, type of investigation, investigation findings and investigation conclusions).The report of "pouch not sealed" was unable to be confirmed through the product evaluation, as the tyvek pouch was not returned.As received, all connections were tight and secure.The kit was primed and flushed without any indication of flow restriction.No leakage was detected during leak test.The dpt (disposable pressure transducer) sensor also zeroed and sensed pressure without any problem.No visible damage/defect was observed from the kit during visual examination.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 100% visual inspection.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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 ; 9492503939
• MDR Report Key: 23787844
• Report Number: 2015691-2025-09962
• Device Sequence Number: 5712213
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)260917(11)240917(10)65997499
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• 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: 09/17/2026
• Device Model Number: PX260
• Device Lot Number: 65997499
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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