MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Lot Number 0031367839

Device Problems Device Contamination with Body Fluid (2317); Detachment of Device or Device Component (2907)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.After two vein ablations the physician noticed blood coming out from the side line of the polarsheath.The head of the sideline detached from the line.The sheath was replaced and the case was completed successfully without any patient complications.

Event Description

During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.After two vein ablations the physician noticed blood coming out from the side line of the polarsheath.The head of the sideline detached from the line.The sheath was replaced and the case was completed successfully without any patient complications.

Manufacturer Narrative

The device was received and analyzed by boston scientific.Visual inspection the luer was not attached to the flush lumen and was not returned.Microscopy inspection examine the flush lumen to find any trace of adhesive that would have been present to keep the luer attached.No visual adhesive was observed on the extension line or inside the luer.The reported allegation of detachment of device component was confirmed.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 17550866
• MDR Text Key: 321191258
• Report Number: 2124215-2023-43532
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Lot Number: 0031367839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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