MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER-TIP

Model Number	PXVPZ30916
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	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use in a patient with this pressure monitoring kit the connection between the z site sampling site and pressure tubing was found detached.This occurred when the patient posture was being adjusted after rehabilitation.There was also backflow of blood into the arterial line.When these malfunctions were found there was no strong tension on the kit.The customer commented it was possible that some pressure had been applied during rehabilitation.There was no allegation of patient injury.The device will be available for product evaluation.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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.
Additional Manufacturer Narrative
One pressure monitoring set was returned for evaluation.Customer report of connection between z site sampling site and pressure tubing was found detached was confirmed.As received, pressure tubing was found completely detached from the distal bond joint with z site.Indication of bonding material was evident on tubing bond surface area.Tubing od measured near the point of detachment was within specification.No visible damage or occlusion was observed from the rest of the kit.Since a lot number was not reported, the device history record review could not be performed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.There are manufacturing controls to avoid potential causes related to the bond - tubing to sample site - detached malfunction as follows: 100% leak test, first unit verification, quality assurance sampling inspection, and 100% visual inspection by manufacturing.

• Brand Name: PRESSURE MONITORING SET
• 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 DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22022477
• Report Number: 2015691-2025-03832
• Device Sequence Number: 12922084
• Product Code: DXO
• UDI-Device Identifier: 07460691949911
• UDI-Public: 07460691949911
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: PXVPZ30916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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