MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10 C; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hair Loss (1877)

Event Date 11/18/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, it was reported to philips that a patient experienced hair loss on the back of the head 6 weeks after the procedure.The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

It has been reported to philips that after following a cerebrovascular procedure, a patient experienced hair loss at the back of the head.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.Based on a patient¿s report of hair loss after a neuro study performed with the philips x-ray system, the customer requested philips to check the system to rule out contribution of the system.The patient in this report received a neuro examination on november 18, 2018, involving almost 40 minutes of fluoroscopy on the same region on the back of the head.The procedure resulted in a total airkerma of 6646 mgy.The procedure was completed successfully.The customer reported hair loss to philips on february 5, 2019.Due to the time elapsed; log files from the day of the procedure are not available for analysis.Philips has inspected the system on-site and confirmed that the system is working according to specification.No malfunction of the system was identified that may have contributed to the hair loss of the patient.Philips concludes that the most likely cause of the hair loss is the high dose (6646 mgy) received by the patient in the same region of the head.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10 C
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8389882
• MDR Text Key: 137803284
• Report Number: 3003768277-2019-00019
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2019
• 2 Devices were Involved in the Event: 1 2

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: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR