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

Model Number	PX284
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	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will 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.It is not known if some procedural factors may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.The lot number was provided and the results of the of the device history record review will be forthcoming once the engineering evaluation is complete.
Event or Problem Description
It was reported that after trouble shooting the monitor and associated parts while attempting to obtain intra-venous pressures the catheter continued measuring negative values between: -2 to -7 mm/hg.Another arrow pressure tubing setup was used to verify inaccurate values.Arrow showed 5-7 mm/hg.Measurements were -venous by both arrow pressure tubings.The pressure transducer was replaced with a new one after all other troubling shooting was performed and the customer was able to measure ideal pressures around 5-7 mm/hg.Which was within expected range for the patient per md provider.No harm came to the patient, the transducer not measuring an accurate value limited the providers ability to make specific diagnosis.The intended procedure was a trans jugular liver biopsy with intra-venous pressure measurements.The patient was not treated based on the inaccurate values; the problem was resolved prior to treatment.Device is not available for return.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19939478
• Report Number: 2015691-2024-05968
• Device Sequence Number: 7433080
• Product Code: DXO
• UDI-Device Identifier: 07460691950214
• UDI-Public: (01)07460691950214(17)250827(11)230828(10)65247549
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 08/27/2025
• Device Model Number: PX284
• Device Lot Number: 65247549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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