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

Model Number	T001709A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this case was not available for evaluation.Nevertheless, imagery was provided for investigation.Based on the review, customer report of pressure tubing issue was confirmed but it was detached rather than broken.Image showed a close up on a male connector of a pressure line.The male connector was noticed completely detached from pressure tubing.What appeared to be blood was evident inside pressure line.No other visible inconsistencies was noticed from image provided.Further investigation was completed by the engineers in the manufacturing site.Based on this assessment, it could be determined that the root cause of this failure was related to an internal component failure.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Based on the available information, no action was required at this time; however, 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 in patient, this disposable pressure transducer tubing broke, causing minimal bleeding from the artery.This caused a disruption in the procedure; the device was replaced with a new unit and the issue was solved.As per customer opinion, the failure appeared to be related to material fatigue or a manufacturing defect.There was no allegation of patient injury.As per image evaluation, pressure tubing was detached rather broken.Patient demographics were not provided.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23905192
• Report Number: 2015691-2025-10611
• Device Sequence Number: 8955238
• Product Code: DXO
• UDI-Device Identifier: 07460691947610
• UDI-Public: (01)07460691947610(17)270415(11)250415(10)66529336
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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 Model Number: T001709A
• Device Lot Number: 66529336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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