MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; Introducer, catheter

Model Number	406136
Medical Device Problem Codes	Fluid/Blood Leak (1250); Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of blood leak from the seal resulting in bleeding was reported.The results of the investigation are inconclusive since the device was not returned for analysis.However, fast-cath hemostasis introducer batch number 8415648 expired on 31/03/2025 which was prior to the reported event date of 04/11/2025.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.Based on the information received, the cause of the reported incident could not be conclusively determined.The cause of the use of expired product is consistent with user error.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During the coarctation stent procedure, blood was observed to leak from the seal.The sheath was replaced but the same issue occurred.The second sheath was replaced, but the same issue occurred again.A smaller sheath was placed within the bigger sheath for hemostasis, but the patient experienced significant blood loss which required volume infusion.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23692375
• Report Number: 3005334138-2025-00729
• Device Sequence Number: 18714255
• Product Code: DYB
• UDI-Device Identifier: 05414734014137
• UDI-Public: (01)05414734014137(10)8415648(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 406136
• Device Catalogue Number: 406136
• Device Lot Number: 8415648
• Was Device Available for Evaluation?: No
• 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: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown