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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 0029569080
Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2022
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.
 
Event Description
During a paroxysmal atrial fibrillation procedure, a polarsheath was selected for use.It was reported that the sheath kinked during insertion into the femoral artery.The patient was obese, weighing 130kg.The procedure was cancelled due to the difficulty.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.Visual inspection revealed no external abnormalities.Functional tests were performed using a field insertion test.The field insertion test was performed with the returned polarsheath and a known good polarx device.No issues were observed, and no unusual resistance was felt during insertion.The reported event was not confirmed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
 
Event Description
During a paroxysmal atrial fibrillation procedure, a polarsheath was selected for use.It was reported that the sheath kinked during insertion into the femoral artery.The patient was obese, weighing 130kg.The procedure was cancelled due to the difficulty.
 
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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 Key15242415
MDR Text Key302331678
Report Number2134265-2022-08556
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 11/30/2022
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 Date04/21/2023
Device Lot Number0029569080
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2022
Initial Date FDA Received08/17/2022
Supplement Dates Manufacturer Received11/04/2022
Supplement Dates FDA Received11/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Weight130 KG
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