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

Lot Number 0029816450

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

It was reported that during a single shot cryoabltion procedure, as the polarsheath, following preparation of the sheath it was observed that the sheath was leaking.It was flushed with a some nacl and it flushed 'weirdish'.The sheath was exchanged with a new polarsheath and the procedure was continued.While preparing the polarx balloon, an error 1 000000020-2 appeared.After disconnecting and reconnecting the gas cable and the electrical cable.The gas cable and the electrical cable were replaced.The procedure was completed without any other issues.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 15550445
• MDR Text Key: 301479256
• Report Number: 2124215-2022-40026
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/06/2022

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: 06/02/2023
• Device Lot Number: 0029816450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1