MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number AZURION 7 M20

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  Injury  

Event Description

It was reported to philips that the azurion 7 m20 system's fluoroscopic image quality was not as expected during a vascular treatment, as the stent seemed to "disappear"/filter away behind the bone structure, and that the stent was not placed in the intended area.According to the customer, they had to place more stents than necessary due to the fact that the stents were ¨somehow misplaced¨.The customer confirmed that this did not impact the patient outcome and the patient is doing well.Customer has reported that this occurred with 3 patients.This report corresponds to the third patient.Philips has started an investigation into this complaint.A follow up report will be submitted when further information is received.

• Brand Name: AZURION
• Type of Device: 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19006771
• MDR Text Key: 338980848
• Report Number: 3003768277-2024-02023
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention