MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Model Number M004CRBS3050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059); Weakness (2145)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure, they had successfully ablated three veins. When they were ablating the last vein (right superior pulmonary vein (rspv)), the physician stopped the ablation due to no effect using a single stop. After the polarx balloon deflated, they observed a small st segment elevation (2mv). The elevation lasted for a minute, and during that minute, after about 30 seconds they got error 1 - 00004000-2: console detected blood in catheter. They immediately pulled out the catheter and found blood inside of the balloon catheter. The blood also got into the cryo gas cable. They exchanged the polarx balloon catheter and the cryo gas cable, and tried again. The exact same problem recurred. This time, the st segment elevation (2mv) lasted for only 30 seconds. They then decided to exchange the polarx balloon catheter, the polarsheath, the polarmap mapping catheter and the cryo gas cable. Afterwards, they were able to ablate the rspv without any further issues and completed the case. The patient was fine when he left the laboratory, without any further events. Six hours after the case, the physician reported that the patient experienced a stroke and that he was being medicated. The patient's status pending. The products are expected to be returned for analysis.

• Brand Name: POLARSHEATH
• 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 Key: 10580701
• MDR Text Key: 208378458
• Report Number: 2134265-2020-13274
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/16/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025818181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• 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: 09/24/2020 Patient Sequence Number: 1