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

Model Number	MKP01464
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was contamination found in the three way stopcock of a pressure monitoring accessory.The appearance was foreign material.The contamination was found during patient use.The user made the decision to complete the procedure using the device.The device was discarded after the procedure was completed.Patient demographics are unavailable.There is no patient harm or injury.
Additional Manufacturer Narrative
The device will not be returned as it was discarded at the facility.The device history record review is pending.Once it has been completed the results will be sent in a supplemental submission.Additional product code, kra, catheter, continuous flush.Additional 510k k896819.
Additional Manufacturer Narrative
The device was discarded at the facility and cannot be returned for product evaluation.The device history record review was completed and all manufacturing inspections passed with no non conformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the issue.Based on the available information, there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.It is not known if procedural factors may have contributed to the event.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 the monthly review.

• Brand Name: TRUWAVE
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; parque industrial de itabo; carr sanchez km 18.5, dominican republic
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19945698
• Report Number: 2015691-2024-06008
• Device Sequence Number: 17982189
• Product Code: DXO
• UDI-Device Identifier: 00690103148190
• UDI-Public: (01)00690103148190
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 07/06/2025
• Device Model Number: MKP01464
• Device Lot Number: ZC1322MT
• Was Device Available for Evaluation?: No
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2023
• 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