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

Model Number	PXVP2284
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: kra.Additional premarket submission: k181684, k896819.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.
Event or Problem Description
It was reported that, during use, a pressure monitoring device had inaccurate pressure readings compared to an arm cuff.A-line read 102/54 and the arm cuff read 197/44.It was stated that the a-line had good square waveform and all appropriate troubleshooting were completed.No allegations of patient injuries.
Additional Manufacturer Narrative
A product evaluation was completed on the returned transducer.The reported event of "inaccurate pressure readings" was unable to be confirmed.Dpt zeroed and sensed pressure accurately on pressure monitor.A pressure of 150 mmhg was applied.Initial pressure reading was 150mmhg and final pressure reading was 150 mmhg.Pressure did not show any drift during output drift testing and met specification.Spec was +/-1 mmhg/8 hour.Electrical testing showed that both input impedance (2,240 ohms) and output impedance (300 ohms) were within specifications.Specifications were 1,200 ohms to 3,400 ohms for input impedance and 285 ohms to 315 ohms for output impedance.Zero-offset (1 mmhg) also met specification.Zero-offset specificaion is +/-25 mmhg.No visible damage was observed from the kit.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no defect was found, a product non-conformance or device failure could not be confirmed and no root cause could be determined.In addition, a device history record review cannot be completed as the lot number was not provided.As part of the manufacturing process 100% of the units go through a flow, leak, voltage, and electrical test.The instructions for use (ifu) states "pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.And "abnormal pressure readings should correlate with the patient's clinical manifestations." instructions include testing dynamic response and notes that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Warning: moisture within the connector may result in the device malfunctioning or in inaccurate pressure readings.If this occurs, replace wet part or parts.

• Brand Name: TRUWAVE, VAMP PLUS
• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23659314
• Report Number: 2015691-2025-09607
• Device Sequence Number: 10055142
• Product Code: DXO
• UDI-Device Identifier: 07460691950177
• UDI-Public: 07460691950177
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: PXVP2284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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