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

Model Number	PX600I
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available to be returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.The device history record review was completed and the product passed without nonconformances.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
As reported during use the pressure monitoring set transducer disconnected spontaneously and csf (cerebrospinal fluid) was leaking out of it.The nurse changed out the transducer per protocol.There was no patient injury.The device is not available for evaluation as it was contaminated and picked up by another company.

• Brand Name: TRUWAVE
• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 24801323
• Report Number: 2015691-2026-13913
• Device Sequence Number: 18508993
• Product Code: DXO
• UDI-Device Identifier: 07460691957077
• UDI-Public: (01)07460691957077(17)270807(11)250807(10)66844009
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: PX600I
• Device Lot Number: 66844009
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 58 KG