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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Lot Number 0029723645
Device Problems Material Perforation (2205); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 30nov2022.Prior to a pulmonary vein isolation procedure a polarmap catheter was selected for use.The polarmap was bent after unpacking and could not be used.The polarmap was replaced, and the surgery was successfully completed without any patient complications.However, device analysis revealed that the shaft was kinked and fractured.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Upon analysis visual inspection revealed the shaft was fractured and broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
Reportable based on device analysis completed on 30nov2022.Prior to a pulmonary vein isolation procedure a polarmap catheter was selected for use.The polarmap was bent after unpacking and could not be used.The polarmap was replaced, and the surgery was successfully completed without any patient complications.However, device analysis revealed that the shaft was fractured.
 
Manufacturer Narrative
G3: aware date corrected from oct 15, 2022 to nov 30, 2022, as the event was reportable based on analysis completed on nov 30, 2022.The device was returned to boston scientific for analysis.Upon analysis visual inspection revealed the shaft was fractured and broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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Brand Name
POLARMAP
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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 Key15987349
MDR Text Key307931222
Report Number2124215-2022-52788
Device Sequence Number1
Product Code DRF
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 12/20/2022
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 Date07/07/2023
Device Lot Number0029723645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2022
Initial Date FDA Received12/15/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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