MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ DUO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 10 F; INTRODUCER, CATHETER

Model Number	406307
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When the procedure was completed, a blood leak was noted from the sheath when removed from the puncture site.It was not the hemostatic valves or flashports.When checked, holes were found in the body of the sheath.It is unclear when the holes were created.There was no resistance at the time of insertion of the sheath.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10f fast-cath duo hemostasis introducer sheath was received for evaluation.The sheath tubing had been punctured mid-sheath; the condition was consistent with the reported fluid leak.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing damage and subsequent fluid leak remains unknown.

• Brand Name: FAST-CATH¿ DUO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 10 F
• 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: 17860221
• Report Number: 3005334138-2023-00451
• Device Sequence Number: 17575207
• Product Code: DYB
• UDI-Device Identifier: 05414734203838
• UDI-Public: 05414734203838
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/16/2023

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: 12/31/2025
• Device Model Number: 406307
• Device Lot Number: 8834165
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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