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

Model Number M004CRBS3050

Device Problem Positioning Problem (3009)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

It was reported that during a cryoablation procedure to treat proximal atrial fibrillation using a polarsheath it was "not possible to insert the lock".It was reported that the patient had an unstable groin area.They attempted pre-stretching the skin with dilators, however, ultimately they were not able to insert the sheath into the patient.Due to the inability to insert the sheath into the patient they were not able to perform the procedure and it was rescheduled for a later date.The sheath is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the sheath was first visually inspected and no abnormalities were seen.They then functionally tested the sheath's valve and found the diameter and tolerances to all be within specifications.They then inspected the distal tip of the sheath, which would enter the body, and no damage or abnormal shaping was noted.In addition, the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on all available information the reported allegation of being difficult to insert could not be confirmed.No issues were found that could cause difficulties when entering the body.

Event Description

It was reported that during a cryoablation procedure to treat proximal atrial fibrillation using a polarsheath it was "not possible to insert the lock".It was reported that the patient had an unstable groin area.They attempted pre-stretching the skin with dilators, however, ultimately they were not able to insert the sheath into the patient.Due to the inability to insert the sheath into the patient they were not able to perform the procedure and it was rescheduled for a later date.The sheath has been 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: 13475401
• MDR Text Key: 287823260
• Report Number: 2134265-2022-01235
• 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
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0027987708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1