MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F; TRANSSEPTAL CATHETER INTRODUCER

Model Number G407376

Device Problem Gas/Air Leak (2946)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, an air leak was noted at the hemostasis valve.The introducer was exchanged and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath was received for evaluation.Functional testing confirmed an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13995045
• MDR Text Key: 288781158
• Report Number: 3005334138-2022-00274
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G407376
• Device Lot Number: 8262448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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