MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

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.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11240011
• MDR Text Key: 229079552
• Report Number: 2134265-2021-00894
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• 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 Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/02/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026053429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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