MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Allura Xper FD; interventional fluoroscopic x-ray system

Model Number	Allura Xper FD20
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/05/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to philips that during an emergency cerebral infarction thrombectomy procedure, the system was unable to emit x-rays and images could not be viewed.A system restart was attempted; however, the issue persisted.The patient was transferred to another system, and the procedure was completed.The reported system issue reportedly resulted in a delay of approximately 50 minutes.It was also reported that severe thrombosis was observed after the guidewire had been inserted.The patient remained in critical condition following the procedure and was subsequently discharged at the family's request.The patient was reportedly alive and not any life-support equipment at the time of discharge.It was subsequently reported that the patient passed away; however, the date and cause of death remain unknown.An investigation into this complaint has been initiated by philips.

• Brand Name: Allura Xper FD
• Common Device Name: interventional fluoroscopic x-ray system
• Manufacturer (Section D): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: marjan vos ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 50451544
• Report Number: 3042175844-2026-002276
• Device Sequence Number: 15893631
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: (01)00884838054202
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Allura Xper FD20
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/26/2026
• Date Device Manufactured: 05/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male