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	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a bentall procedure during which the introducer was placed in the patient.During routine manipulation of the introducer, the sideport separated from the device.No extra force was used and no antiseptic was used on the device.Sterile gloves and a sterile compress were initially used to block the hole at the point of separation, then a 3-way extension was forcibly connected to prevent air intrusion.The introducer was replaced which resolved the issue and the procedure was completed with no adverse consequences to the patient.It is unknown how long the introducer was inside the patient prior to the reported sideport detachment.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 one 8.5f fast-cath introducer sheath and dilator were received for evaluation.The extension tubing had detached from the sideport of the hemostasis body.A corrective action was initiated to investigate the failure mode of the sideport detachments.

• 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: 22168185
• Report Number: 3005334138-2025-00315
• Device Sequence Number: 9218217
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: (01)05414734012751(10)10648006(17)271130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/10/2025

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: 10648006
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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
• Patient Sex: Unknown