MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE

Lot Number 0031292267

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

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during preparation for a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath the flush port was found to be separated from the irrigation tubing of the sheath handle.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the sheath was visually inspected which revealed that the irrigation tubing was completely separated from the luer fitting joint of the sheath handle.The reported allegation of irrigation failure was confirmed, and the root cause for the occlusion was traced to manufacturing deficiency as the luer had not been properly connected due to a lack of adhesive.Separated tubing would prevent irrigation fluid from entering the sheath and proper irrigation would be unable to occur.

Event Description

It was reported that during preparation for a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath the flush port was found to be separated from the irrigation tubing of the sheath handle.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received by boston scientific for analysis.

• Brand Name: POLARSHEATH
• Type of Device: VASCULAR GUIDE CATHETER, SINGLE-USE
• 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: 17666131
• MDR Text Key: 322446910
• Report Number: 2124215-2023-46329
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Lot Number: 0031292267
• 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
• Date Device Manufactured: 03/23/2023
• 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