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

Model Number	PX272
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient received a magnetic resonance imaging (mri) thermal burn while connected to this pressure monitoring system.The transducer was located at the patient's humerus and connected to an iradimed arterial line line monitoring pod.The patient required wound consults and medicated cream for the thermal injury on the right humerus.No surgical intervention was required.The customer confirmed that there was no product non-conformance with the pressure monitoring kit and they will provide education to their hospital staff regarding mri safety.
Additional Manufacturer Narrative
No product was 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 lot number was not provided thus a device history record was not reviewed.The instructions for use provides the following statements regarding mri safety: this device and the associated cable are not intended for use inside of the bore of the mr system and should not be in contact with the patient.This device and the associated cable may be in the mr system room but not in operation or connected to a pressure monitoring system during an mr examination.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.Additional fda premarket submission: k171996 and k183413.

• 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 LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21715551
• Report Number: 2015691-2025-02338
• Device Sequence Number: 20019928
• Product Code: DXO
• UDI-Device Identifier: 07460691950207
• UDI-Public: 07460691950207
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PX272
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown