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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

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

It was reported that during a cryoablation procedure with a polarsheath, the physician experienced issues with the leaking sealing lip of the sheath.The leakage from the sheath was only noticed when the physician did an angiogram of the left atrium (la) and pulmonary veins with a 5fr multipurpose catheter.The small leakage during the angiogram did not persist after the small catheter was taken out or during the cryoablation with polarx balloon catheter inside the sheath.The tools/devices placed across the valve were the polarsheath dilatator, the 5fr multipurpose for the angiogram, the polarx 28mm balloon catheter and the guiding wire.The patient had a significantly increased left atrial (la) pressure, so no air was sucked in or leaked, but a mix of blood and saline continuously dripped out of the hemostatic valve of the sheath.The increased la pressure was not a result from the procedure, it was already persistent prior to the procedure and was only noticed during the beginning of procedure.The case was completed successfully (all four isolated veins) with the same sheath without patient complications.The polarsheath was returned.

• 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: 10791147
• MDR Text Key: 216931386
• Report Number: 2134265-2020-15311
• 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: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

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 Date: 05/05/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025634106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1