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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; VASCULAR GUIDE CATHETER, SINGLE-USE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE Back to Search Results
Lot Number 0030946919
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 06/12/2023
Event Type  Injury  
Event Description
During a polarx case a polarsheath was selected for use.There was a huge transient st elevation only during the first seconds of ablation on lspvs.The patient was under general anesthesia.After the preparation of the polarsheath; flushed with a syringe of 20 cc of saline water with the edge higher than the handle), the dilator was slowly removed and they let the blood flow out and at the same time they tap the 3-way with a syringe.Catheter preparation include inflation and air bubble removal in a bowl with saline water.The embolism was resolved in some minutes by providing high volume of oxygen.The console had a strange behavior linked to valve sv8: the balloon can be inflated only in slow mode.There were no errors that occurred during the case.The patient fully recovered and was discharged from the hospital.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory.Functional testing revealed the sheath passed all functional testing with no issues.Visual examination revealed the sheath valve was visibly damaged upon return.No damage or defects were observed with the device that could have resulted in the patient impact of air embolism and st segment elevation.The events reported are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.
 
Event Description
During a polarx case a polarsheath was selected for use.There was a huge transient st elevation only during the first seconds of ablation on lspvs.The patient was under general anesthesia.After the preparation of the polarsheath; flushed with a syringe of 20 cc of saline water with the edge higher than the handle), the dilator was slowly removed and they let the blood flow out and at the same time they tap the 3-way with a syringe.Catheter preparation include inflation and air bubble removal in a bowl with saline water.The embolism was resolved in some minutes by providing high volume of oxygen.The console had a strange behavior linked to valve sv8: the balloon can be inflated only in slow mode.There were no errors that occurred during the case.The patient fully recovered and was discharged from the hospital.
 
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Brand Name
POLARSHEATH
Type of Device
VASCULAR GUIDE CATHETER, SINGLE-USE
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 Key17199369
MDR Text Key317840547
Report Number2124215-2023-32674
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 Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/11/2023
Device Lot Number0030946919
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2023
Initial Date FDA Received06/26/2023
Supplement Dates Manufacturer Received08/25/2023
Supplement Dates FDA Received09/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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