MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722023

Device Problem Human-Device Interface Problem (2949)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888)

Event Date 06/11/2015

Event Type  Death  

Event Description

Philips received a complaint from a customer that during tavi (transcatheter aortic valve implantation), patient had hemorrhage.Customer tried to use xper ct to find hemorrhage area.However customer could not give xper ct exposure.So they cannot find hemorrhage area.As a result, patient died due to dic (disseminated intravascular coagulation).

Manufacturer Narrative

When investigation is completed a follow up report will be sent to fda.(b)(4).

• Brand Name: ALLURA XPER FD20 OR TABLE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 4850628
• MDR Text Key: 5931414
• Report Number: 3003768277-2015-00050
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2015

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: 722023
• Device Catalogue Number: 722023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death