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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.Nevertheless, imagery was provided for investigation.Based on the image review, the report of "black flocculent material observed inside of one tubing" was confirmed.The image showed a close-up of a pressure tubing on top of a tyvek pouch from the reported model and lot.What appeared to be a flocculent black material could be observed inside the fluid path.No other visible inconsistencies were noticed.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.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 flushing of this pressure monitoring set prior to patient connection, a black flocculent material was observed inside of one tubing.There was no patient involvement, since the issue was detected during the preparation stage in the preparation room.The device was not available for evaluation, as it was discarded.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) - code 4112 - analysis of information provided by user/third party chosen since the correct code "analysis of images" is not available.Updated section h6 (component code), 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.Based on the review of the manufacturing process, the tubing involved is subjected to a standard, validated cutting operation, which does not introduce known mechanisms for foreign particle generation.The product was not returned, and the particulate was not able to be evaluated, therefore its composition remains unknown.Therefore, the root cause of this event could not be conclusively determined within apms process scope.It was verified that there are manufacturing controls to related to the related 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 (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: 24267969
• Report Number: 2015691-2026-10828
• Device Sequence Number: 10021018
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)261218(11)241218(10)66132582
• 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): 03/12/2026

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 Model Number: PX260
• Device Lot Number: 66132582
• Was Device Available for Evaluation?: No
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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