MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20

Model Number 722006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Radiation Burn (1755)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Philips received a complaint from a customer that pt received radiation burn.The procedure was extremely difficult procedure with complications during this procedure.Physician forced to proceed as pt was in danger of losing a kidney due to obstructed blood flow.The procedure was successful.

Manufacturer Narrative

Pr#: (b)(4).When investigation is completed, a follow up report will be sent to the fda.

• Brand Name: ALLURA XPER FD20
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dominic siewko ; 3000 minuteman rd; ms 4-235; andover, MA 01810 ; 9786597936
• MDR Report Key: 4172825
• MDR Text Key: 5157710
• Report Number: 3003768277-2014-00114
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

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: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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