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Model Number M004CRBS3050
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Muscle Spasm(s) (1966); Muscle Weakness (1967); ST Segment Elevation (2059); Loss of consciousness (2418); Cognitive Changes (2551); Complete Heart Block (2627); Convulsion/Seizure (4406); Heart Block (4444); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event Description
It was reported that during a cryoablation procedure to treat paroxysmal atrial fibrillation with a polarsheath, after removing the dilator from the sheath in the left atrium (la), blood was aspirated (16cc) and followed by air. The air origin was not clear (sheath valve or 3-way stopcock). While inserting the polarsheath into the left atrium, the dilator was removed as usual, as slowly as possible. Once removed, blood was aspirated with a syringe. At first, this was normal, but after around 16cc of blood, air followed. The 3-way stopcock was closed. However additional air entered into the system subsequently and within 1 second, no more blood could be seen in the tube connecting the sheath handle to the stopcock. The 3-way stopcock was opened again to aspirate the air. They at first aspirated 30cc of air, before blood again was aspirated without additional appearance of air. A flush line was connected as usual. St segment elevations started to occur, and the physician started mitigation acts: trendelenburg tilting the table, ventricular pacing in anticipation of av-block that subsequently also did occur and in order to advance the air through the coronaries as quickly as possible. On fluoroscopy, air was suspected in the aortic root. A pigtail catheter was advanced retrogradely into the aortic root in order to attempt to aspirate the air. However, once the pigtail was in the aortic root, most of the air could no longer be seen. Coronary angiography of the coronary artery (rca) was performed, and the vessel was open without detectable air. The patient was hemodynamically stable with volume supplementation at any time. Both the av-block as well as the st-elevations resolved within about 15 minutes. At that point in time, the decision was taken to pursue the cryoablation in this clearly symptomatic patient, which was successfully completed uneventfully in less than 30 minutes. On awaking from the propofol sedation, the patient had spastic extremities and a hemisyndrome on the left side. She was able to talk and was fully oriented. A computed tomography (ct) scan was performed and showed diffuse hypoperfusion of the right hemisphere. As per neuroradiology and neurology, those changes were indicative of a post-seizure state. Anti-seizure treatment was started. Over the course of the next five hours, the patient's neurological state deteriorated. The patient experienced an air embolism and was hemineglect. An electroencephalogram (eeg) ruled out a potential seizure, which was a potential diagnostic of the ct scan. Cerebral magnetic resonance imaging (mri) did not show signs of a stroke nor ischemia or bleeding. The patient was intubated. No vascular obstruction was seen. A delayed perfusion of the right hemisphere was seen. As per neuroradiology and neurology, those changes were still more compatible with a post-seizure state than with a stroke. Twelve hours later, the patient was still intubated. Despite stopping the sedation, she had not woken up, but was spontaneously breathing. Three days post procedure, the patient woke up and was talking, oriented and moving both arms and legs.
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Manufacturer (Section D)
302 parkway
global park, la aurora
Manufacturer (Section G)
302 parkway, global park
la aurora - heredia
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
MDR Report Key11240011
MDR Text Key229079552
Report Number2134265-2021-00894
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2021
Device Model NumberM004CRBS3050
Device Lot Number0026053429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/27/2021 Patient Sequence Number: 1