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

Model Number 722028

Device Problems Device Inoperable (1663); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which is stated that during an endovascular aneurysm repair procedure the fluoroscopy unit failed which resulted in the emergency need for a mobile c-arm with sub-optimal visualization resulting in a sub-optimal and less accurate stent deployment.This resulted in an 80% narrowing of the left renal artery and some compromised kidney function.The doctor was able to stent that artery last friday in a secondary procedure with a nice result and the kidney function was checked again this week which showed some improvement but it is not 100% back to normal yet.Short-circuiting in some form has occurred multiple times, but not with such a direct impact on a patient resulting in an unnecessary additional procedure as well as possible long term health consequences.

Manufacturer Narrative

The imaging module of the system was replaced and since then no other issues have been reported.The replaced module has been extensively tested for its nominal (voltage, data transfer) and additional (temperature, hot plug-in/plug-off) performance parameters.No failure was found.The visual inspection of the module did not confirm any issue.The user made a statement about a ¿short-circuiting in some form¿.However philips has not been able to confirm any malfunction (short circuit, or other failure).

• Brand Name: ALLURA XPER FD20
• 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 (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 6507516
• MDR Text Key: 73260711
• Report Number: 3003768277-2017-00041
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722028
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 72