MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PEDIASAT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	XT3515SJ
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dqe, dxg.Additional premarket submission: k110167.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.However, a device history record cannot be completed without a serial number 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
As reported, after catheter placement during use in patient when blood backflow was checked, a pediasat oximetry catheter aspirated air.It is unclear which lumen (distal, medial, proximal) aspirated air.No medication leakage occurred.After the catheter removal, the customer performed a test in the water and found a hole on the patient (distal) side of backform, and leakage was observed from the same location.There was no allegation of patient injury.
Additional Manufacturer Narrative
The catheter was returned for product evaluation.The reported event of leakage issue was confirmed.Leakage was detected from backform to catheter body junction when distal lumen was pressurized.All other through lumens were patent without any leakage or occlusion.No other visible inconsistency was observed from the returned catheter.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/design defect.As part of the manufacturing process, 100% of the units go through a leak test.

• Brand Name: PEDIASAT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23770701
• Report Number: 2015691-2025-09929
• Device Sequence Number: 9743305
• Product Code: DRE
• UDI-Device Identifier: 00690103197570
• UDI-Public: 00690103197570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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
• Device Model Number: XT3515SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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