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

Lot Number 0028029009

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 1jul2022.It was reported that during a procedure to treat paroxysmal atrial fibrillation a polarx balloon was unable to be inserted on a crbs polarsheath steerable sheath.It was possible to advance 2 cm in the sheath and then it was blocked.The issue was solved by exchanging the sheath and the procedure was successfully completed with no patient complications.However, investigation revealed that there was buildup of an undetermined material in the inner diameter of the valve housing that limited the insertion of the unit.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection passed after inspection to critical regions related to allegation.After functional test, it was found that there was buildup of an undetermined material in the inner diameter of the valve housing that limited the insertion of the unit.A.140 gauge was used and was not able to fit through the housing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 14989078
• MDR Text Key: 295819488
• Report Number: 2134265-2022-07852
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Lot Number: 0028029009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1