MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406948
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, there was a leak from the hemostasis valve of the introducer.The sheath was exchanged and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.The dilator was also received.Functional testing confirmed a fluid and an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in the proximal face of the seal and on the side wall of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak is consistent with damage during use.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.

• Brand Name: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES 63 CM LE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11999615
• Report Number: 3005334138-2021-00399
• Device Sequence Number: 11872025
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 7700414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1