EP Mapping Catheter Survey

1
EP Mapping Catheter Survey

• David S. Buckles, PhD, FACC
• Cardiac Electrophysiology and Monitoring Branch
• Division of Cardiovascular Devices
• Office of Device Evaluation
• Center for Devices and Radiological Health
• U.S. Food and Drug Administration
• MedSun Conference
• November 17-18, 2004

2
EP Mapping Catheters

• Used in the electrophysiology (EP) lab to detect
  and record electrical activity
• Indicated for diagnosis of arrhythmias

3
PV Mapping Catheter

• Special variant of EP mapping catheter
• Designed to be used in the left atrium in or near
  the ostia of the pulmonary veins
• Unique design - distal loop has memory shape and
  cannot be straightened remotely
• First device cleared in 2000 several currently
  on the market

4
PV Mapping Catheters

• In 2003 FDA began hearing about possible problems
  unique to PV mapping catheters
• Received at least four Medical Device Reports
  (MDR) of adverse events, including disabling
  injury
• At least two reports in medical literature of
  adverse events, including entrapment and device
  fracture
• These reports raised the possibility that there
  were safety issues specific to this type of
  catheter due to the distal loop architecture

5
PV Mapping Catheters

• We didnt have enough information to determine
  whether there was a problem with these devices
• To investigate whether there was a public health
  issue, we needed to know
• whether there really was a problem specific to
  these devices, distinct from risks commonly
  associated with EP catheters
• the nature and severity of adverse events
• the rate of adverse events relative to usage
  rates
• If there was a public health issue, this
  information would allow us to ask the
  manufacturers to develop and promulgate risk
  mitigation strategies

6
PV Catheters Initial Survey

• Fortunately, the MedSun system provided a means
  to get some answers
• To see if there was any cause for concern at all,
  we did a Rapid Response Survey of nine MedSun
  sites
• Of the six responders with EP labs, three
  reported using the device
• Of the three users, all three reported at least
  one adverse event
• We thought this was suggestive of a problem

7
PV Catheters Full Survey

• With the RRS results in hand, plus the MDR and
  literature reports, we obtained authorization for
  a full survey of several hundred sites
• Survey is currently in progress, should finish by
  end of 2004
• Survey managed by Office of Surveillance and
  Biometrics (OSB) working with CODA
• All survey results de-identified before review by
  CDRH / ODE / DCD

8
PV Catheter Survey Results

• MedSun survey results as of 11/5/2004
• 99 sites surveyed
• 46 of these have EP lab
• 21 of these use the PV mapping catheters
• Of these 21 users, three reported adverse events
• More data are coming in, and final results should
  be very interesting in terms of numbers, rates
  and types of adverse events
• The final results will be analyzed to determine
  whether further action by FDA is warranted

9
Conclusions

• MedSun system provided a responsive,
  cost-effective, timely means for assessing a
  possible health hazard with a specific medical
  device
• Participation by MedSun sites had a direct impact
  on public health policy and management of
  cardiovascular devices

10
Questions/Comments?

• David S. Buckles, PhD, FACC
• dsb_at_cdrh.fda.gov
• Tel. [phone] x 174
• Elias Mallis
• Branch Chief
• Dr. Bram Zuckerman,
• Division Director

11
Thank You