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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 0030706441
Device Problems Leak/Splash (1354); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
It was reported that the sheath exhibited a hemostatic valve leak.During a procedure a polarsheath was selected for use.All cooling was completed, the polarx cryoablation catheter was removed, and a non-bsc ring catheter was inserted (which constitutes off-label use of the sheath); however, blood slowly started flowing from the hemostatic valve of the sheath.Since there was not enough blood loss to require replacement, the procedure was completed using the device as it was.No patient complications were reported.The device has been returned for analysis.
 
Manufacturer Narrative
The polarsheath was returned to boston scientific for laboratory analysis.A visual inspection did not reveal any damage that would lead to blood leaking from the hemostatic valve; however, the hemostatic valve was found to have a large tear which was visible under microscopy.This tear is likely the cause for the leak seen in the field.The tear was separate from the manufacturing slit.Functional testing was also performed, which the sheath failed in some parameters.During a leakage test the device was gently pressurized with 6 psi at the flushing line lure fitting while plugging the distal tip of the sheath, and the pressure decay value for the sheath passed.The device passed a hemostatic valve test without a dilator inserted.The sheath was able to maintain a minimum pressure of 5.5 psi.No leaks were observed.During an aspiration test no air was visible in the flushing line during test/syringe vacuum, though the device failed a 10 cc syringe with draw (approx 1 cc per second) test as well as a 60 cc syringe with draw (approx 30 cc per second) test.Bubbles were visible in the flushing line during test/syringe vacuum in those tests.The polarsheath was used with a ring catheter (non-bsc device) used during procedure which constitutes off label use.Laboratory analysis confirmed the reported clinical observation.
 
Event Description
It was reported that the sheath exhibited a hemostatic valve leak.During a procedure a polarsheath was selected for use.All cooling was completed, the polarx cryoablation catheter was removed, and a non-bsc ring catheter was inserted (which constitutes off-label use of the sheath); however, blood slowly started flowing from the hemostatic valve of the sheath.Since there was not enough blood loss to require replacement, the procedure was completed using the device as it was.No patient complications were reported.The device has been returned for analysis.
 
Event Description
It was reported that the sheath exhibited a hemostatic valve leak.During a procedure a polarsheath was selected for use.All cooling was completed, the polarx cryoablation catheter was removed, and a non-bsc ring catheter was inserted (which constitutes off-label use of the sheath); however, blood slowly started flowing from the hemostatic valve of the sheath.Since there was not enough blood loss to require replacement, the procedure was completed using the device as it was.No patient complications were reported.The device has been returned for analysis.
 
Manufacturer Narrative
The polarsheath was returned to boston scientific for laboratory analysis.A visual inspection did not reveal any damage that would lead to blood leaking from the hemostatic valve; however, the hemostatic valve was found to have a large tear which was visible under microscopy.This tear is likely the cause for the leak seen in the field.The tear was separate from the manufacturing slit.Functional testing was also performed, which the sheath failed in some parameters.During a leakage test the device was gently pressurized with 6 psi at the flushing line lure fitting while plugging the distal tip of the sheath, and the pressure decay value for the sheath passed.The device passed a hemostatic valve test without a dilator inserted.The sheath was able to maintain a minimum pressure of 5.5 psi.No leaks were observed.During an aspiration test no air was visible in the flushing line during test/syringe vacuum, though the device failed a 10 cc syringe with draw (approx 1 cc per second) test as well as a 60 cc syringe with draw (approx 30 cc per second) test.Bubbles were visible in the flushing line during test/syringe vacuum in those tests.The polarsheath was used with a ring catheter (non-bsc device) used during procedure which constitutes off label use.Laboratory analysis confirmed the reported clinical observation.
 
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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 Key16549655
MDR Text Key311401337
Report Number2124215-2023-09936
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/24/2023
Device Lot Number0030706441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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