MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; INTRODUCER, CATHETER

Model Number	406804
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, a fluid leak was noted at the level of the non-return valve of the sheath resulting in a liquid entry into the stereotaxis systemr.The procedure continued with no consequences to the patient.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath was received for evaluation.Functional testing confirmed a fluid 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seals and subsequent leak remains unknown.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• 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: 14016016
• Report Number: 3005334138-2022-00278
• Device Sequence Number: 4558846
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: 05414734203302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 8078455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown