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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

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Difficult to Remove (1528)
Patient Problem Hematoma (1884)
Event Date 10/06/2020
Event Type  Injury  
Event Description
It was reported that a polarx cryo ablation balloon catheter was used in a pulmonary vein isolation procedure. After the transseptal puncture performed the polarsheath , polarmap and polarx were then prepared and inserted successfully. The target lesion of the left superior pulmonary vein grade 4 occlusion was then ablated successfully. The physician then moved onto the left interior pulmonary vein with a grade 3-4 occlusion which was also performed successfully. The physician then moved to the right side of the heart to right superior pulmonary vein when a blood detection error (error 1 - 00004000-2) occurred after inflation. The polarx was deflated using the slider switch, removed from the polar sheath and the polarx and cryo-cables were replaced. A new polarx catheter and cryo-cable was connected and a blood detection error occurred again while balloon outside of patient. The cryo-cable was disconnected and reconnected. Then the polar x was prepped and inserted into the polar sheath without any issues. The ablation of the right superior pulmonary vein was performed successfully with no issues to the pacing of the phrenic nerve. The physician then encountered difficulties positioning the polarx at the right inferior pulmonary vein(ripv) while targeting ripv, potential air embolism as noticed by st segment elevation on ecg occurred. The polarx was removed from the polarsheath and a coronary sinus catheter was used to find the ripv. Once the ripv signals were found the cs catheter was switched out for the polarx. When the polarx was reinserted into the polarsheath during inflation the blood detection error occurred again. The polarx was deflated using the slider switch but the physician noticed that the balloon was stuck in the polarsheath. The polarx was then re-inflated then deflated with the slider switch however was still unable to removed. The physician then asked for another physician for help, it was then noticed that the proximal shaft of catheter was kinked. While trying to remove the polarsheath and the catheter from the left atrium, they "slipped" into the right atrium. When they tried to remove polarsheath and catheter from patient, they discovered that the balloon and tip were no longer attached to catheter shaft, it was also noted that there was blood in the cryo-cable. Fluoroscopy imaging showed that balloon was stuck in femoral vein. The balloon and tip were successfully removed from the femoral vein of patient by vascular surgical team. It was noted that post procedure the patient developed hematomas after the procedure, which were treated. The patient was monitored overnight, and was reported to be doing better. However, the patient will continue to be monitored.
 
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Brand NamePOLARSHEATH
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 Key10778904
MDR Text Key214407448
Report Number2134265-2020-15209
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/24/2021
Device Model NumberM004CRBS3050
Device Lot Number0025710273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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