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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; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE Back to Search Results
Lot Number 0032305269
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
Event Type  malfunction  
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.
 
Event Description
During a cryoablation procedure a polarx st fit catheter was prepared with the polarmap catheter.One electro cardioversion was performed with 300 joules.In total 10 freezes were completed.One vein was not isolated.In body time under 60 minutes, with no errors and no complications.The procedure was completed without any patient complications.When the physician removed the polarx st fit with the polarmap and the physician observed broken plastic between the polarmap electrodes, and the wire between the electrodes was shown.The device is expected to return.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed that the polarmap had a break towards the proximal end of the shaft.The distal loop has a break and wire exposure between electrodes 4 and 5.The plastic deformation does not appear to have resulted from getting caught or snagged on another object.The stretching of the plastic appears uniform, as if it ballooned out from an internal pressure.A crystalized dry substance can be seen inside the plastic and on the wiring, which resembles dried contrast.All electrodes measured as open, confirming that the wires were broken at the location of the shaft break.It is assumed that the wire breaks occurred during shipping and handling after the procedure given that the polarmap functioned as expected during the procedure.The wires showed no signs of damage in the distal loop.The physician of this case is known to use an acist contrast delivery system, labelled up to 600psi, as part of her workflow.Contrast was moved through the shaft of the polarx over the polarmap.Contrast delivery systems are labeled up to 600psi.Given the ballooning effect observed in the distal loop plastic and the break in the shaft, it was assumed that the shaft break occurred when inserting the polarmap into the polarx, contrast made its way into the break and up the shaft of the polarmap when using the acist, and the pressure buildup inside the device caused the distal loop to balloon out between electrodes 4 and 5, and subsequently break.To confirm the possibility of this, deionized (di) water was pushed through the shaft of the polarmap.Water drops were coming out the distal loop, confirming the path.
 
Event Description
During a cryoablation procedure a polarx st fit catheter was prepared with the polarmap catheter.One electro cardioversion was performed with 300 joules.In total 10 freezes were completed.One vein was not isolated.In body time under 60 minutes, with no errors and no complications.The procedure was completed without any patient complications.When the physician removed the polarx st fit with the polarmap and the physician observed broken plastic between the polarmap electrodes, and the wire between the electrodes was shown.The device is expected to return.
 
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Brand Name
POLARMAP
Type of Device
CARDIAC MAPPING CATHETER, PERCUTANEOUS, 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 Key17966388
MDR Text Key326321141
Report Number2124215-2023-57892
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032305269
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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