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

Model Number M004CRBS3050

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

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The polarsheath was returned to boston scientific for analysis.To assess the valve housing minor diameter, the shaft was almost entirely removed.A small portion of shaft was left adhered to the valve housing, to preserve the shaft to housing bond interface.The dissection and dimensional inspection of the valve housing identified that the housing id was below the minimum specification.There was buildup of an undetermined material in the inner diameter (id) of the valve housing that limited the insertion of the unit.During the operations performed the material in the port was loosened and dislodged out but the material in the id continued to limit entry.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

Reportable based on analysis completed on (b)(6) 2021.During a pulmonary vein isolation cryoablation procedure to treat paroxysmal atrial fibrillation, a polarx balloon catheter and a polarsheath were selected for use.It was reported that strong resistance was felt when the physician attempted to insert the catheter into the sheath.With additional force, the catheter was inserted inside the sheath, past the hemostatic valve.The procedure resumed and the left superior pulmonary vein was occluded successfully.At the end of the procedure, a strong resistance was also observed when the catheter was removed from the sheath.No patient complications were reported.However, device analysis revealed buildup of an undetermined material in the inner diameter of the valve housing that limited the insertion of the sheath.

• 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: 12480584
• MDR Text Key: 272870513
• Report Number: 2134265-2021-11713
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025728762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1