MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F; INTRODUCER, CATHETER

Model Number	406701
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a portion of the fast-cath introducer detached and remained in the patient.When removing a non-abbott (bostonscientific) faradrive introducer & farawave catheter, and fast cath introducer from the right femoral vein, the fast cath introducer snapped and was left within the body.A vascular surgeon was required to perform a cut down at the femoral vein to attempt to retrieve the separated sheath.This was unsuccessful.The introducer was then retrieved using a snare and removed through the non-abbott (bostonscientific) faradrive introducer.The patient is stable.It is alleged by the physician that the cause was either due to the punctures being two close and the non-abbott (bostonscientific) faradrive introducer squished the fast cath introducer or the introducer was sutured too tightly and snagged upon removal.The physician did not allege an performance issues with the abbott introducer.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.An event of material separation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23043183
• Report Number: 3005334138-2025-00549
• Device Sequence Number: 18614442
• Product Code: DYB
• UDI-Device Identifier: 05414734216944
• UDI-Public: (01)05414734216944(10)10554638(17)270930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/07/2026

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: 406701
• Device Catalogue Number: 406701
• Device Lot Number: 10554638
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown