MAUDE Adverse Event Report: BOSTON SCIENTIFIC TSX FIXED CURVE TRANSSEPTAL SHEATH

Model Number M004TSXFS800

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2015

Event Type  malfunction  

Event Description

Tsx fixed curve transseptal sheath leaking at the stopcock.Replaced with another of the same brand of sheath and it was leaking as well.

• Brand Name: TSX FIXED CURVE TRANSSEPTAL SHEATH
• Type of Device: TSX FIXED CURVE TRANSSEPTAL SHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 5330167
• MDR Text Key: 34568977
• Report Number: MW5058759
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M004TSXFS800
• Device Lot Number: Q828044
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR