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

Model Number	406137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
While doing a follow-up check after a temporary pacemaker implantation procedure, the sideport detached from the introducer.The introducer was exchanged which resolved the issue.The patient is stable and with no adverse consequences.
Event or Problem Description
This report includes an updated analysis.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.Corrected information: h6.The reported event of sideport detachment was confirmed.The device was not returned for analysis; however, one image was submitted to product performance engineering for evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based solely upon the aforementioned image, the sideport appeared to be detached from the introducer.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h11.Corrected information: h6.
Event or Problem Description
This report includes updated investigation coding.

• 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: 23749986
• Report Number: 3005334138-2025-00747
• Device Sequence Number: 18483087
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: (01)05414734012751(10)10619426(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 04/29/2026

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 Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 10619426
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 04/29/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/19/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown