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

Model Number 722003

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Philips received a complaint from the customer that due to a long procedure (3 hours) the patient received a high cumulative air kerma of 14 gy.

Manufacturer Narrative

Philips has investigated the complaint and came to the following conclusion: the medical case started as a left coronary catheter procedure but complications led to a pci (percutaneous coronary intervention) resulting in a very long time for the patient on the table.The root cause of the high dose is the length of the pci procedure as indicated by an attending nurse.A philips application specialist made calculations and concluded that; the total dose of 14.1 gray can be the result of the very long fluoroscopy time, with a normal dose rate and the 50 exposure runs.The conclusion of the analysis is therefore that the high dose is caused by the length of the procedure, resulting in more than 3 hours of fluoroscopy time, with normal dose rates.(b)(4).

• Brand Name: ALLURA XPER FD10
• 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
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5146940
• MDR Text Key: 28141456
• Report Number: 3003768277-2015-00084
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• 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: Followup
• Report Date: 09/17/2015

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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