MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TSX FIXED CURVE TRANSSEPTAL SHEATH; TRANSSEPTAL INTRODUCER

Model Number FCL-191-01

Device Problem Air Leak (1008)

Patient Problem Air Embolism (1697)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

The device in this case has been discarded by the user.No photographs were provided.The device history was reviewed and found no excursions.Proper materials and methods of manufacturing were utilized.

Event Description

It was reported that the proximal part of the transseptal sheath, the hemostatic valve, got lost two times.They tried to fix it once by plugging it onto the sheath again.The sheath continued to be used.The second time, the valve got lost again and air got into the sheath.The patient got an air embolism.This was reported by the nurse from the hospital.This was reported one week after the event.No information about intervention or patient status was provided.The product was also disposed of, so analysis cannot be performed.

• Brand Name: TSX FIXED CURVE TRANSSEPTAL SHEATH
• Type of Device: TRANSSEPTAL INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley parkway; malvern PA 19063
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 65 great valley pkwy; malvern PA 19355
• Manufacturer Contact: stephanie glatts ; 65 great valley pkwy; malvern, PA 19355 ; 6105915093
• MDR Report Key: 5624889
• MDR Text Key: 44285572
• Report Number: 2529252-2016-00002
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: FCL-191-01
• Device Lot Number: Q856502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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 Outcome(s): Life Threatening