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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 0030185997
Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2022
Event Type  malfunction  
Event Description
It was reported that during a cryoablation procedure to treat an atrial fibrillation in the atrium, a polarsheath was selected for use.After the sheath was inserted into the body, the balloon catheter was inserted into the sheath.At that time, back blood was drawn by connecting a syringe to the side port, but air was drawn into the side port.Also, when air was being removed a kink occurred.Sheath was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Sheath was returned to boston scientific corporation for laboratory analysis.
 
Manufacturer Narrative
Polarsheath steerable sheath was evaluated by boston scientific corporation.Functional test was performed, and the sheath passed all standard manufacturing testing.The sheath was able to hold pressure while pressurized at 5.5 psi in hemostasis testing.Visual inspection noted there was no kink observed during inspection of the returned sheath.Based on all the available evidence the conclusion is that no problem was detected with the returned device, the reported allegation of air in the device could not be replicated, and no other issues were found with the device.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The ifu states "do not aspirate via the side port if the sheath lumen is occupied (i.E., by the dilator or components of the cryoablation catheter) as the aspiration may draw air across the sheath valve into the polarsheath.", as investigation found no defect with the device, if any air was seen in the sheath the most likely cause would have been use of the device that was contradictory to the provided instructions.
 
Event Description
It was reported that during a cryoablation procedure to treat an atrial fibrillation in the atrium, a polarsheath was selected for use.After the sheath was inserted into the body, the balloon catheter was inserted into the sheath.At that time, back blood was drawn by connecting a syringe to the side port, but air was drawn into the side port.Also, when air was being removed a kink occurred.Sheath was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Sheath was returned to boston scientific corporation for laboratory analysis.
 
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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 Key15960290
MDR Text Key306091287
Report Number2124215-2022-51323
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/02/2023
Device Lot Number0030185997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2022
Initial Date FDA Received12/12/2022
Supplement Dates Manufacturer Received12/20/2022
Supplement Dates FDA Received01/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2022
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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