MAUDE Adverse Event Report: ST. JUDE MEDICAL AFOCUS 2; CATHETER, ELECTRODE RECORDING

Model Number IBI-87008

Device Problem Air Leak (1008)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Low Oxygen Saturation (2477)

Event Date 03/13/2017

Event Type  Injury  

Event Description

This event occurred within a trans-septal puncture to access the left atrium.Introduction of the "a-focus 2 catheter (st.Jude medical) into the agilis med curl sheath (st.Jude medical) is thought to have introduced air into the left atrium which is thought to have caused an rv infarct ischemia.The introduction of afocus through sheath hemostasis valve has been described as "cumbersome".Procedure note is as follows: the st.Jude afocus 20 pole mapping catheter was inserted into the agilis sheath using its accompanying introducer.This was done while flushing the side-port of the agilis to prevent introduction of air.However, within a minute, there st elevations were noted 12 lead ecg, and the patient became hypotensive.Code blue was called and brief acls algorithm was initiated which included chest compression for 30 seconds, intubation, a bolus of epinephrine iv, high-flow oxygen started for presumed air embolus, and a synchronized shock for atrial fibrillation with rapid ventricular response, which converted the patient to a different atrial flutter afterward.The agilis sheath and afocus catheter was also immediately pulled back into the ra.St elevations and hypotension recovered within one minute, consistent with a coronary air embolus.A 5 fr femoral arterial line was placed in preparation for possible coronary angiogram.However, in discussion with our interventional cardiology service, it was felt that this event was due to air embolus and not due to an acute thrombotic event since it resolved so quickly, and ice images showing that lv systolic function had recovered to normal.Therefore, coronary angiography was deferred.However, the bp gradually decreased over the next 20 minutes.During this time, ice images showed newly reduced rv systolic function, underfilled lv, no pericardial effusion, and (at most) a very small inter-atrial shunt.Epinephrine, milrinone and inhaled nitric oxide was started, which increased the bp back to normal.Exacerbation of the patient's pulmonary hypertension, triggering rv failure was also diagnosed.At this point, a right heart catheterization was performed to assess hemodynamics using a 7.5 fr vip swan ganz catheter, which was inserted into the 8 fr sheath.The pressures were the following: ra 11 mmhg, rv 51/8 mmhg, pa 56/23 mmhg, and pcwp 16 mmhg.Oxygen saturation was also performed, which showed the following: pa 75.6 percent, rv 72.7 percent, ra 73.7 percent, svc 84.0 percent, and ivc 61.7 percent.These oxygen saturations were not consistent with a large left-to-right shunt.Lack of profound hypoxemia excluded a large right-to-left shunt.No significant inter-atrial shunt was seen on ice.Due to the above events, we decided to abort the rest of the electrophysiology procedure.From (b)(6) note: (b)(6) with diastolic hr and pulmonary hypertension presented today for atrial flutter ablation.During the case she had a hemodynamic decompensation consistent with rca air embolism with acute rv dysfunction.She was intubated and required brief cpr and dccv for vt.A pac was placed and she was brought to the cvicu on low dose milrinone and epinephrine.Of note, it appeared she responded well to oral pulm vasodilators with rsvp estimated on echos from 80 to 33 mmhg.However, on the tee the day after she was seen in ep clinic, this again showed rsvp of 80.Here in the icu, her pa systolic pressure is in her 80's again, on ino.

• Brand Name: AFOCUS 2
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 6420397
• MDR Text Key: 70592897
• Report Number: MW5068558
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: IBI-87008
• Device Lot Number: 5713321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 81 YR
• Patient Weight: 70