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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 0032570201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Event Date 02/14/2024
Event Type  Injury  
Event Description
It was reported a cardiac tamponade occurred.The procedure was cancelled.During a cryoablation procedure to treat atrial fibrillation (a fib), an nrg transseptal needle was selected for transeptal puncture.The patient anatomy was difficult and had the inferior vena cava connected to the right atrium from the right side than usual.The transseptal puncture was performed without any issues.There was no issues noted during the transseptal puncture.A polarsheath, polarx balloon, polarmap catheter were also used during the procedure.The patient's blood pressure decreased, and cardiac tamponade was diagnosed.Cardiac tamponade occurred just after transseptal puncture before sheath entered the left atrium and ablation was conducted.Pericardial drainage was performed, and the procedure was cancelled.The patient has been discharged from the hospital.The device has been returned for analysis.
 
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.
 
Manufacturer Narrative
B2 outcomes attrib to adv event: corrected f10 patient codes: corrected the device was returned to boston scientific for analysis.The polarx device was visually inspected for any damage or defects that would have resulted in the issue seen in the field.No visual damage or defects were observed.The device was assessed with an isaac pressure decay testing system to determine if any potential leak paths existed that may have contributed to the patient complications of tamponade observed in the field.The polarx device was connected to the smartfreeze gold system in attempt to test the functionality of the device.Two 120 second ablations were performed with a known-good cryo-cable.The device passed console testing with no issues.
 
Event Description
It was reported a cardiac tamponade occurred.The procedure was cancelled.During a cryoablation procedure to treat atrial fibrillation (a fib), an nrg transseptal needle was selected for transeptal puncture.The patient anatomy was difficult and had the inferior vena cava connected to the right atrium from the right side than usual.The transseptal puncture was performed without any issues.There was no issues noted during the transseptal puncture.A polarsheath, polarx balloon, polarmap catheter were also used during the procedure.The patient's blood pressure decreased, and cardiac tamponade was diagnosed.Cardiac tamponade occurred just after transseptal puncture before sheath entered the left atrium and ablation was conducted.Pericardial drainage was performed, and the procedure was cancelled.The patient has been discharged from the hospital.The device has been returned for 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 Key18860910
MDR Text Key337156331
Report Number2124215-2024-14071
Device Sequence Number1
Product Code OAE
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
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number0032570201
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received03/07/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NRG TRANSSEPTAL NEEDLE; NRG TRANSSEPTAL NEEDLE; POLARMAP; POLARMAP; POLARSHEATH; POLARSHEATH
Patient Outcome(s) Other; Required Intervention;
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