MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILLIPS ALLURA XPER; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 20/10 RELEASE 8.1

Device Problem No Display/Image (1183)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Patient here for pda occlusion.Patient was hemodynamically tenuous and critically ill.Lateral camera stopped working during occluder deployment and with repositioning.Required snaring and re-capture of migrated device with unreliable ability to perform fluoroscopy.Increased procedure time, radiation, contrast delivered for angiogram that was not stored (increase risk of contrast induced nephropathy.System is not logging in the error when it fails.Image processor drives due to age.There has been no harm to any patient as a result of this device.

• Brand Name: PHILLIPS ALLURA XPER
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• MDR Report Key: 15311174
• MDR Text Key: 298971342
• Report Number: MW5111750
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2022

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: 20/10 RELEASE 8.1
• Device Catalogue Number: 001446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 26 WK
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Hispanic
• Patient Race: White