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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARXFIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARXFIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Lot Number 0031104335
Device Problems Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2023
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
It was reported that during the preparation of a procedure to treat an atrial fibrillation (afib), a polarxfit catheter was selected for use.During balloon preparation on the very beginning of the case all recommended procedural steps were followed.During connection of the y-adapter to the flush port(side port), the team noticed that flush port (side port) was not working and was broken and leaking fluid.Catheter was replaced and the issue was resolved.The procedure was completed without any other issues.The patient was not harmed or in danger during the troubleshooting period.Catheter is expected to be returned for further analysis.
 
Manufacturer Narrative
Polarxfit catheter was evaluated by boston scientific.Visual inspection noted the flush port had no physical damage.A syringe with water was attached to the flush port to test patency of the device.There was no issue affixing the syringe to the flush port.No fluid or air could be pushed through the device.The flush lumen was found to be occluded with a substance later determined to be contrast used during procedure.The length of the catheter guidewire lumen had contrast present that was sticky in nature and could not be flushed out of the guidewire lumen.It is believed this contrast contributed to the event due to fluid not being able to being able to be pushed through at the flush lumen.This may present as fluid leaking out of the flush port at the syringe and flush port interface.The catheter was dissected to retrieve the substance occluding the guidewire lumen.The substance was sent to the analytical lab to identify.It was found to be a type of procedure related contrast.Laboratory analysis was unable to confirm the reported clinical observation of leak flush port damage.Analysis found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.Device was found within specifications.
 
Event Description
It was reported that during the preparation of a procedure to treat an atrial fibrillation (afib), a polarxfit catheter was selected for use.During balloon preparation on the very beginning of the case all recommended procedural steps were followed.During connection of the y-adapter to the flush port(side port), the team noticed that flush port (side port) was not working and was broken and leaking fluid.Catheter was replaced and the issue was resolved.The procedure was completed without any other issues.The patient was not harmed or in danger during the troubleshooting period.Catheter was returned to boston scientific for laboratory analysis.
 
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Brand Name
POLARXFIT
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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 Key17857106
MDR Text Key324784540
Report Number2124215-2023-52476
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeHR
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
Report Date 11/30/2023
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 Lot Number0031104335
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2023
Initial Date FDA Received10/02/2023
Supplement Dates Manufacturer Received11/15/2023
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2023
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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