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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During atrial fibrillation procedure after placing the sheath into the patient, air was aspirated into a syringe that connects to the extension port of the sheath.Several aspirations were attempted which did not resolve the issue.The device was replaced 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.A leak was noted at the hemostasis valve during functional testing.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 is consistent with damage during use.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
• MDR Report Key: 11197448
• MDR Text Key: 228855577
• Report Number: 3005334138-2021-00036
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 05/31/2023
• Device Model Number: G407376
• Device Lot Number: 7547575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1