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

Model Number	PXVPZ10914
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.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 before use in patient, a lint ball like foreign material was found inside the tubing of this pressure monitoring kit.The packaging was opened.There was no allegation of patient injury.
Additional Manufacturer Narrative
One single dpt - vamp plus kit was returned for evaluation.The customer report of foreign material inside the tubing was confirmed.An unknown dark brown particulate, approximately 5.5cm cm distal from proximal sampling site was observed inside pressure tubing.The particulate was approximately 2mm x 5mm, attached to the inner wall of pressure tubing.The particulate stayed at the same location on pressure tubing after 5 minutes of continuous flushing.A chemistry analysis was performed on the particulate however, the ir spectrum analysis of the particulate was inconclusive since absorption characteristics were similar to various materials.An engineering evaluation was then initiated to assess for any manufacturing related processes which could be correlated to the complaint.During the execution of the engineering evaluation process, it was identified that the involved device is manufactured by infus, a third party manufacturer.These devices are not processed internally in the bd apm manufacturing process.The infus investigation concluded that the event could be related to their manufacturing process.From reviewing the complaint description and photos, the brown material could be the burnt pvc material in the tube, and it was not detected during the inspection.Therefore based on the available information there is no evidence that supports or confirms the failure mode is associated to a bd apm manufacturing or design defect.As part of the manufacturing process 100% of the units go through a bd apm visual inspection.The device history record review was also performed and the product passed without nonconformances.

• 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): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23556633
• Report Number: 2015691-2025-09281
• Device Sequence Number: 10081588
• Product Code: DXO
• UDI-Device Identifier: 00690103216806
• UDI-Public: 00690103216806
• 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): 01/28/2026

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: PXVPZ10914
• Device Lot Number: CK0276MT
• Was Device Available for Evaluation?: Yes
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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