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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Brain Injury (2219); Convulsion/Seizure (4406)
Event Date 03/10/2021
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 atrial fibrillation, an air embolism occurred through this polarsheath's stop-cock valve after the sheath was advanced into the left atrium and the dilator was removed. The embolism was noted through st segment elevations visible on the heart monitor. The sheath was retracted into the right atrium to prevent further air ingress into the left atrium and the procedure was terminated. Additional intervention was performed to recanalize the patient's right coronary artery, which was occluded by air. The subsequent angiography of the vessels supplying the brain did not show any major vessel rupture (could not be adequately assessed intracranially). The patient was admitted to the intensive care unit (icu) and, as status epilepticus was suspected, was transferred to the neurology department's icu on the same day. Additional information was received that during the ablation procedure, the polarsheath had at one time been removed and reinserted into the patient. In addition, a multipurpose catheter was placed across the sheath's hemostatic valve to visualize the ostia of the pulmonary veins. It was also reported that the ablation procedure was conducted according to the trained actions and applications recommended from boston scientific. No further information was available about what additional devices/tool were in place when the air ingress occurred. The patient had normal thrombospondins (tsp) prior to the event. It was also reported that this patient exhibited very heavy breathing which, despite the gudel tube, was associated with heavy snoring and deep thoracic lifting and lowering. The physicians suspect that the patient's condition caused a negative intrathoracic pressure gradient that led to significant pressure variation in the patient's heart. This pressure variation resulted in air entrainment through the sheath's hemostatic valve (potential air volume of 20-30ml). Six days later, it was reported that the patient still had a slight right-sided hemiparesis but was sitting at the edge of the bed again and ingesting food. The patient was moved out of the icu but currently remains hospitalized and closely monitored; it is anticipated that the patient will make a full recovery. The polarsheath was retained by the hospital and boston scientific is currently negotiating its return so laboratory analysis can be conducted.
 
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Brand NamePOLARSHEATH
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 Key11581343
MDR Text Key242693052
Report Number2134265-2021-04013
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberM004CRBS3050
Device Lot Number0026219010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction Number92688876-FA

Patient Treatment Data
Date Received: 03/29/2021 Patient Sequence Number: 1
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