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

Model Number	58K16906
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pressure monitoring accessory was returned for evaluation.The customer report of malfunction was confirmed.No visible inconsistency was observed from returned pressure tubing unit.However, the returned extra male connector appeared to be detached from pressure tubing.Detached tubing was not returned for evaluation.An engineering evaluation is anticipated.However, the complaint cannot be confirmed without the completion of the evaluation.The device history record review could not be completed since the lot number is unknown.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, the pressure monitoring accessory experienced an unknown malfunction.There was no allegation of patient injury and the issue was resolved by replacing the device.Upon return of the device the initial evaluation confirmed that the extra male connector appeared to be detached from pressure tubing.
Additional Manufacturer Narrative
One set of pressure tubing with attached three-way stopcock, model # 58k16906 and an extra male connector was returned for evaluation.The customer report of a malfunctioning device was confirmed.No visible inconsistency was observed from the returned pressure tubing unit.However, the returned extra male connector appeared to be detached from pressure tubing.Detached tubing was not returned for evaluation.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to this complaint.Based on the available evidence a root cause was unable to be determined.During the manufacturing process there are controls to detect the malfunction reported, such as visual inspection and a flow test by manufacturing.A pull test and visual inspection is also performed by quality assurance.A personnel notification that was rendered to prevent this type of reported malfunction was sent to all personnel that perform the bonding operation of these components.The device history record review was not completed as a lot number was not provided.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.

• 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 LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21764623
• Report Number: 2015691-2025-02558
• Device Sequence Number: 8676442
• Product Code: DXO
• UDI-Device Identifier: 07460691952355
• UDI-Public: 07460691952355
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Model Number: 58K16906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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