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	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, this disposable pressure transducer tubing had black unknown substances inside.There was no allegation of patient injury.
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
Added: h2 (type of follow-up report).Updated: b5 (event description), g3 (date received by manufacturer), g6 (type of report), h6 (component code, type of investigation, investigation findings, investigation conclusions).The device involved in this case was received by our product evaluation laboratory.An unknown black particle, approximately 2x3 mm in size, was found inside pressure tubing at 26 cm from distal male luer.Unknown particulate appeared attached to inner surface of pressure tubing.The particle did not dislodge during 5 minutes of continuous flushing.No particulates found on filter paper.The particulate was sent to chemistry lab for further analysis.Ir spectrum of unknown material showed similar absorption characteristics when comparing to polyvinyl chloride (pvc) like material.Evaluation results revealed that the reported event was confirmed.Further investigation was completed by the engineers in the manufacturing site.It was determined that this issue is potentially related to the supplier process; therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Consequently, no further action is required at this time; however, all events will continue to be reviewed and monitored.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.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, before use in patient, this disposable pressure transducer tubing had black unknown substances inside (see image attached).There was no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; 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: 24741442
• Report Number: 2015691-2026-13688
• Device Sequence Number: 9230314
• Product Code: DXO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2026

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: 66023143
• 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: 03/14/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 07/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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