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

Model Number	406180
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, after the transeptal puncture, blood leaked from the hemostasis valve of the sheath.The sheath was replaced, and the procedure was completed with no adverse consequences to the patient.Only viewflex catheter was inserted into the sheath.The transseptal needle was from japanlife line.The model and lot number are unknown.The devices inserted directly into the hemostatic valve until the reported event occurred were the dilator and viewflex.No abnormalities were noted with the first device inserted into the sheath¿s hemostasis valve.There was no movement of air into the patient¿s body.No additional puncture at the access site was necessary during sheath replacement.
Additional Manufacturer Narrative
One 10f fast-cath introducer sheath was received for evaluation.A dilator from current inventory was inserted and removed from the sheath.An aspiration vacuum leak test was conducted; no air aspirated into the syringe.A pressure leak test (liquid method) was also conducted; no leaks were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22341648
• Report Number: 3005334138-2025-00395
• Device Sequence Number: 18431934
• Product Code: DYB
• UDI-Device Identifier: 05414734014410
• UDI-Public: (01)05414734014410(10)10707618(17)280131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/23/2025

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: 406180
• Device Catalogue Number: 406180
• Device Lot Number: 10707618
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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