MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS Q FLOOR ANGIOGRAPHY SYSTEM

Model Number 10848280

Device Problems Failure to Transmit Record (1521); Failure to Advance (2524)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 11/22/2016

Event Type  Injury  

Event Description

The pt was undergoing urgent cardiac catheterization for evolving st elevation myocardial infarction.After a single cineangiogram was obtained, there was complete failure of the imaging gantry, such that no repositioning of the image intensifier was possible.Multiple emergent procedures to free the table and gantry failed.Attempts to advance a guidewire into the left anterior coronary artery (lad) were not successful due to the inability to visualize the origin of the lad (which was severely overlapped with the left main coronary artery and left circumflex in the only view available.) the pt was rotated on the table to permit visualization of the lad origin.However, these maneuvers were not successful.During this time, and despite escalation of levophed for blood pressure support, the pt became bradycardic and progressively hypotensive.Transient cardiopulmonary resuscitation was performed.The pt was emergently transferred to an alternative cath lab for continuation of the procedure.After rapid re-preparation of the pt, the lad was wired.There was a complex thrombotic and calcified stenosis at the origin of the very large 2nd diagonal branch.A stent was successfully positioned and deployed.Cineangiography was performed in multiple projections to confirm good angiographic result.The pt continued to be hypotensive despite revascularization of the lad and mid lad (d2), therefore right heart catheterization was carried out and a right ventricular assist device (impella) was placed.The pt was transferred to the coronary intensive care unit (ccu) for further management.As a result of the failure of the imaging gantry, re-opening the occluded lad was delayed during which time the pt became hemodynamically unstable, sustained a transient cardiac arrest and likely extended the size of the myocardial infarction.

• Brand Name: ARTIS Q FLOOR ANGIOGRAPHY SYSTEM
• Type of Device: ANGIOGRAPHY SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; malvern PA
• MDR Report Key: 6154447
• MDR Text Key: 61891142
• Report Number: MW5066579
• 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: Physician
• Type of Report: Initial
• Report Date: 12/02/2016

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: 10848280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 73