MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE

Lot Number CL12383

Device Problem Leak/Splash (1354)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a faradrive sheath a leak was present.After inserting the sheath into the patient and starting irrigation fluid was observed to be leaking from the valve.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is not expected to be returned for analysis as it was disposed of by the site.

• Brand Name: FARADRIVE STEERABLE SHEATH CLEAR
• Type of Device: VASCULAR GUIDE-CATHETER, SINGLE-USE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19038768
• MDR Text Key: 339321589
• Report Number: 2124215-2024-20118
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2024
• 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
• Patient Sex: Female