MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE, VAMP; CATHETER, CONTINUOUS FLUSH

Model Number	PXVMP172AT3
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	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dxo.Additional premarket submission: k173586, k896819.A product evaluation was completed on the returned pressure monitoring kit.The reported event of "could not be primed" was not able to be confirmed.Returned kit was able to be primed without indication of flow restriction and flushed without any problem.Flush device functioned properly.However, as received, pressure tubing was found completely detached from vamp reservoir bond joint.There was no clear indication of bonding material on tubing bond surface area.Tubing outer diameter was within specification.No other visible damage or inconsistency was found to the returned kit.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.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 device prep, a pressure monitoring kit could not be primed properly.Issue was resolved by exchanging the device.Although the issue caused a delay in treatment, there were no patient injuries.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.Based on the available information and previous evaluations, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.As part of the manufacturing process ,100% of the units go through a visual and functional inspection.

• Brand Name: TRUWAVE, VAMP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21866217
• Report Number: 2015691-2025-03026
• Device Sequence Number: 12722994
• Product Code: KRA
• UDI-Device Identifier: 07460691950405
• UDI-Public: (01)07460691950405(17)261001(11)241001(10)66030637
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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
• Device Expiration Date: 10/01/2026
• Device Model Number: PXVMP172AT3
• Device Lot Number: 66030637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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