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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 0033568871
Device Problems Difficult to Remove (1528); Communication or Transmission Problem (2896); Material Integrity Problem (2978)
Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918); Perforation (2001)
Event Date 04/08/2024
Event Type  Injury  
Event Description
It was reported that the patient experienced a perforation.During a cryoablation procedure to treat paroxysmal atrial fibrillation (paf), a polarmap, polarsheath and were selected for use.There was also another unknown catheter for c-map in the superior vena cava (svc).During the procedure, the patient's saturation decreased to 82 percent, and they experienced bleeding in the mouth after cryoablation in the order of left inferior pulmonary vein (lipv), left superior pulmonary vein (lspv) and right superior pulmonary vein (rspv).The procedure was discontinued, and they switched to artificial respiration.The patient's saturation was stabilized, and the patient was discharged from the catheterization laboratory.Atrial esophageal fistula did not occur.It was reported that there were no problems with the appearance or functionality of the polarmap before use.However, after catheter removal, problems with the appearance were observed.It was also reported that when the polarmap was inserted in the rspv, the potential of electrode number 8 was not visible.The potential that could not be seen was no longer visible after that.It was also difficult to return the polarmap back into the balloon when removing the catheter.The physician reported that the polarmap caused the perforation.The catheter has been returned for analysis.
 
Event Description
It was reported that the patient experienced a perforation.During a cryoablation procedure to treat paroxysmal atrial fibrillation (paf), a polarmap, polarsheath and were selected for use.There was also another unknown catheter for c-map in the superior vena cava (svc).During the procedure, the patient's saturation decreased to 82 percent, and they experienced bleeding in the mouth after cryoablation in the order of left inferior pulmonary vein (lipv), left superior pulmonary vein (lspv) and right superior pulmonary vein (rspv).The procedure was discontinued, and they switched to artificial respiration.The patient's saturation was stabilized, and the patient was discharged from the catheterization laboratory.Atrial esophageal fistula did not occur.It was reported that there were no problems with the appearance or functionality of the polarmap before use.However, after catheter removal, problems with the appearance were observed.It was also reported that when the polarmap was inserted in the rspv, the potential of electrode number 8 was not visible.The potential that could not be seen was no longer visible after that.It was also difficult to return the polarmap back into the balloon when removing the catheter.The physician reported that the polarmap caused the perforation.The catheter has been returned for analysis.It was further reported that the physician thinks that the polarmap might have caused a lung perforation.However, there was no imaging to confirm that.Additionally, after the removal of the catheter, the shaft and ring were twisted, with a wire protruding from the ring part.
 
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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 Key19173765
MDR Text Key340939862
Report Number2124215-2024-24857
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeJA
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 04/29/2024
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? Yes
Device Operator Health Professional
Device Lot Number0033568871
Was Device Available for Evaluation? No
Date Returned to Manufacturer04/17/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/24/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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