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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; CATHETER, STEERABLE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE Back to Search Results
Lot Number 0028853609
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2022
Event Type  malfunction  
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
During an atrial fibrillation procedure, a polarsheath was selected for use.It was reported that after the physician inserted the sheath into the patient and removed the dilator with the wire, he tried to aspirate.Only air was removed.The hemostatic valve was plugged with a finger, and it was possible to aspirate some blood.The sheath was replaced, and the procedure was completed successfully.No patient complications were reported.
 
Event Description
During an atrial fibrillation procedure, a polarsheath was selected for use.It was reported that after the physician inserted the sheath into the patient and removed the dilator with the wire, he tried to aspirate.Only air was removed.The hemostatic valve was plugged with a finger, and it was possible to aspirate some blood.The sheath was replaced, and the procedure was completed successfully.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.Visual inspection noted no abnormalities.Functional tests were performed, and the sheath failed standard manufacturing testing when air was observed in the flush line during the aspiration test.The sheath passed the hemostasis valve test which was released without a dilator inserted during the test.The sheath was able to maintain the appropriate pressure.An air pressure test was performed to find the location of leaks.The sheath handle was disassembled to find the area where the leak occurred, and no leak was found.The reported field observation was confirmed through cis analysis.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.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 (92688876-fa) 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.
 
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Brand Name
POLARSHEATH
Type of Device
CATHETER, STEERABLE
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 Key15321151
MDR Text Key302603277
Report Number2124215-2022-33274
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 Physician
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/23/2022
Device Lot Number0028853609
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Removal/Correction Number92688876-FA
Patient Sequence Number1
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