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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARX; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARX; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Lot Number 0032272644
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
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.
 
Event Description
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarx fit catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.
 
Manufacturer Narrative
Additional information added to b5: describe event or problem.It was indicated that the device will not be returned for evaluation.It was further reported via additional information that the device became unsterile while being handled by the nurse during preparation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarx fit catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.It was further reported that the catheter was looped on the patient field.It became unsterile when unwrapped and it hit the scrub nurse in the head.
 
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Brand Name
POLARX
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 Key18364447
MDR Text Key331314412
Report Number2124215-2023-72194
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032272644
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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