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

Model Number	406182
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
The following event was received from a voluntary medwatch report: the patient was on the cardiac treatment unit in (b)(6) 2025.While preparing to remove the sheath from the groin, the nurse noted bleeding from the groin.Upon removal of the sheath, a hole was noted; the bleeding from the groin was coming from the hole in the sheath.Manual compression was applied for 40 minutes to stop the bleeding.The patient was discharged later that night with no further issues.The sheath had been used for approximately 2 hours that day.

• 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: 23640597
• Report Number: 3005334138-2025-00719
• Device Sequence Number: 9805629
• Product Code: DYB
• UDI-Device Identifier: 05414734012904
• UDI-Public: 05414734012904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Model Number: 406182
• Device Catalogue Number: 406182
• 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: 11/10/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White