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

Model Number	PX260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this complaint was received by our product evaluation laboratory for a full examination.The report of part loose was confirmed.As received, all connections were tight and secure.No leakage was detected from the kit during leak test.However, filter was found dislodged inside drip chamber during visual examination.No other visible damage or inconsistency was observed from the kit.Further engineering investigation is being performed, when the product investigation is completed, a supplemental report will be sent with the investigation results.
Event or Problem Description
As reported, when setting up this disposable transducer, a part was loose.No further information available.There is no allegation of patient injury.As per product evaluation findings, filter was found dislodged inside drip chamber during visual examination.Patient demographics were not provided.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (investigation findings) and h6 (investigations conclusions).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.It was determined that this issue is related to the supplier process; therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Additionally, there are manufacturing controls for the reported malfunction.

• 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 Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23988585
• Report Number: 2015691-2026-10222
• Device Sequence Number: 17300873
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)270220(11)250220(10)66273564
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Device Model Number: PX260
• Device Lot Number: 66273564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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