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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; VASCULAR GUIDE CATHETER, SINGLE-USE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE Back to Search Results
Lot Number 0031151151
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Event Description
It was reported that during a cryoablation procedure to treat a paroxysmal atrial fibrillation, polarsheath was selected for use.After the physician completed ablation on the left side pulmonary vein, they attempted to use the polarsheath to access the right inferior pulmonary vein.Detachment of the irrigation port was noticed during manipulation of the polarsheath and polarx catheter.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.The device is expected to be 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
The polarsheath device was returned to boston scientific for analysis.Upon receipt at boston scientific post market laboratory, visual inspection noted the luer was detached from the extension line and was not returned with the device.The flush lumen was examined under microscopy to look for any trace of adhesive that would have been present to keep the luer attached.No adhesive was observed on the extension line.With all the available information, boston scientific concludes the reported failure of detached irrigation port was confirmed through investigational analysis.Based on the available information the root cause of the observed event was manufacturing deficiency.
 
Event Description
It was reported that during a cryoablation procedure to treat a paroxysmal atrial fibrillation, polarsheath was selected for use.After the physician completed ablation on the left side pulmonary vein, they attempted to use the polarsheath to access the right inferior pulmonary vein.Detachment of the irrigation port was noticed during manipulation of the polarsheath and polarx catheter.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.
 
Event Description
It was reported that during a cryoablation procedure to treat a paroxysmal atrial fibrillation, polarsheath was selected for use.After the physician completed ablation on the left side pulmonary vein, they attempted to use the polarsheath to access the right inferior pulmonary vein.Detachment of the irrigation port was noticed during manipulation of the polarsheath and polarx catheter.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.
 
Manufacturer Narrative
The polarsheath is en-route back to boston scientific but the device has not been received for analysis yet.Therefore, a failure analysis of the complaint device has not been completed.However, pictures of the reported failure were provided.Based on the available information, the reported failure of detached irrigation port was confirmed with a root cause of manufacturing deficiency.
 
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Brand Name
POLARSHEATH
Type of Device
VASCULAR GUIDE CATHETER, SINGLE-USE
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 Key18021365
MDR Text Key326733508
Report Number2124215-2023-59703
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K223824
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 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/10/2024
Device Lot Number0031151151
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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