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

Model Number	VMP306PX
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the pressure monitoring set the team noticed that the line stopped reading.Upon checking the line the team discovered bubbles in the line and attempted to clear them but kept pulling air and could not identify where the air was coming from.They found that the air was in the syringe connected to the line to take a blood sample.They did look at the fluids handing and there were was not any air in the bag or the line.This was used in conjunction with the argyle umbilical vessel catheter 3.5 french.There was no patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: kra - catheter, continuous flush.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 been completed as the 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
The device was not 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.A device history record review was unable to be completed as the lot number is unknown.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no device was returned, a product non-conformance or device failure could not be confirmed and no root cause could be determined.As part of the manufacturing process 100% of the units undergo visual inspection, manufacturing continuous monitoring sampling, and a qa sampling inspection as well as a leak and flow test.

• Brand Name: TRUWAVE, VAMP JR.
• 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: 24097418
• Report Number: 2015691-2026-10467
• Device Sequence Number: 13361439
• Product Code: DXO
• UDI-Device Identifier: 07460691950375
• UDI-Public: 07460691950375
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: VMP306PX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/06/2026
• 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
• Patient Sex: Unknown