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

Model Number ALLURA XPER FD20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hair Loss (1877)

Event Date 06/08/2021

Event Type  Injury  

Event Description

It has been reported to philips that the patient experienced hair loss after undergoing a brain arteriovenous malformation procedure on the philips allura x-ray system.The patient received a total dose of 7.4 gy during a total irradiation time of 4 hours and 35 minutes.Philips inspected the system onsite and analyzed the log file and no malfunction was found.Deterministic effects or tissue reactions may occur when the radiation dose has exceeded a certain threshold level, which may depend on the irradiated tissue or organ and on the patient's sensitivity to radiation.The threshold is typically 3 gy for temporary hair loss.Deterministic effects are described in the instructions for use (b)(4).

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12487875
• MDR Text Key: 271896960
• Report Number: 3003768277-2021-10118
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K161563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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): Other
• Patient Age: 17 YR