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

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

During a polarx procedure a polarsheath was selected for use.After ablation of one or two veins the connection piece of the irrigation tube on the sheath fell off.The physician noticed this immediately and put a clamp on the irrigation line to prevent the sheath from drawing air.The sheath was then replaced to complete the procedure without any patient complications.

Manufacturer Narrative

Intial reporter phone: (b)(6).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory.Visual examination revealed the luer was detached from the extension line.Microscopy inspection revealed a slight strip of potential adhesive was noted on the flush lumen and inside of the luer.The reported allegation of irrigation failure was confirmed.

Event Description

During a polarx procedure a polarsheath was selected for use.After ablation of one or two veins the connection piece of the irrigation tube on the sheath fell off.The physician noticed this immediately and put a clamp on the irrigation line to prevent the sheath from drawing air.The sheath was then replaced to complete the procedure without any patient complications.

• 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; boston scientific corporation; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17556089
• MDR Text Key: 321237511
• Report Number: 2124215-2023-41387
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1