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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); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Event Date 09/22/2021
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. To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device. On april 13, 2021, boston scientific issued a field safety notice (b)(4) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.
 
Event Description
During an pulmonary vein isolation (pvi) cryoablation procedure to treat atrial fibrillation (af) a polarsheath was selected for use. After bringing the polarsheath forward and removing the dilator, approximately 20ml of air was observed. Angiography of all four veins was performed, the patient became bradycardic with st elevation. Air embolism was diagnosed. The artery which was blocked by air as recanalized. The cryoablation procedure was cancelled and the patient was stable and transferred to intensive care unit for observation. The patient has fully recovered. The device is expected to be returned to boston scientific for analysis. This product is part of the (b)(4) advisory population for the polarsheath steerable sheath.
 
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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 Key12591289
MDR Text Key275383248
Report Number2134265-2021-12574
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/02/2022
Device Model NumberM004CRBS3050
Device Lot Number0027353327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown
Removal/Correction Number92688876-FA

Patient Treatment Data
Date Received: 10/07/2021 Patient Sequence Number: 1
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