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

Model Number	406136
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a cryo procedure, a blood leak was noted at the hemostasis valve.Another sheath from the same lot was used to complete the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One 14f fast-cath 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 seal was microscopically inspected.Tearing, resulting in a hole, was noted in the distal face of the seal, at both ends of the seal slit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn and stretched seal, and subsequent leak, remains unknown.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.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 HEMOSTASIS 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: 15925419
• Report Number: 3005334138-2022-00667
• Device Sequence Number: 17740556
• Product Code: DYB
• UDI-Device Identifier: 15414734014134
• UDI-Public: 05414734014137
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K914090
• 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): 01/12/2023

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: 02/28/2025
• Device Model Number: 406136
• Device Catalogue Number: 406136
• Device Lot Number: 8393499
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 60 KG