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

Model Number	T001744M
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use of this pressure monitoring set in the previous 1-2 weeks, damped waveform was observed, so device was checked and confirmed there were no kinks and saline bag was fully pressurized.After removing the line, blood clot appeared.The device was not available for evaluation.
Additional Manufacturer Narrative
No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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 of this pressure monitoring set, damped waveform was observed.The device checked and confirmed there were no kinks and saline bags were fully pressurized.After removing the line, blood clot appeared at the distal end of the line.Pressure line needed to be replaced every 4-6 hours.No further information was available.There was no allegation of consequences for the patient reported.
Additional Manufacturer Narrative
Updated section b5, h6 (investigation findings) and h6 (investigations conclusions).Added information to section g1 (address).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 manufacturing controls to avoid potential causes related to the related malfunction.Patient demographics 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; 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: 21891018
• Report Number: 2015691-2025-03156
• Device Sequence Number: 14313238
• Product Code: DXO
• UDI-Device Identifier: 07460691959507
• UDI-Public: (01)07460691959507(17)260503(11)240503(10)65735924
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/09/2025

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: 05/03/2026
• Device Model Number: T001744M
• Device Lot Number: 65735924
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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