MAUDE Adverse Event Report: SIEMENS AG SIEMENS ARTIS Q. ZEN; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10608967

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Radiation Overdose (1510); Vascular Dissection (3160)

Event Date 01/30/2014

Event Type  Injury  

Event Description

X-ray exposure failed in the process of deploying a stent.The stent deployed in an improper position that caused dissection.The pt had to be moved to another lab to treat the improper placement and dissection.This caused the pt to receive excessive x-ray exposure.

• Brand Name: SIEMENS ARTIS Q. ZEN
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG; siemensstrasse 1; forcheim 9130 1; GM 91301
• MDR Report Key: 3660838
• MDR Text Key: 4197206
• Report Number: MW5034794
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/19/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 10608967
• Device Catalogue Number: ARTIS Q. ZEN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR