MAUDE Adverse Event Report: Abbott Medical Fast-Cath¿ Transseptal Guiding Introducer; Introducer, Catheter

Model Number	407436
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the pfo procedure, a femoral vein dissection was noted during transseptal puncture after a puncture of the fast-cath sheath.Under fluoro it was noted that the needle was observed passing through the wall of the fast-cath introducer.The brk needle and the fast-cath sheath were removed from the patient.It was noted that the patient experienced a femoral vein dissection without any other complication.There were no interventions performed and the patient remained stable.

• Brand Name: Fast-Cath¿ Transseptal Guiding 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 ; +1(651)756-5400
• MDR Report Key: 50883396
• Report Number: 3005334138-2026-00458
• Device Sequence Number: 10708335
• Product Code: DYB
• UDI-Device Identifier: 05414734203647
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K964518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 407436
• Device Catalogue Number: 407436
• Device Lot Number: 11236226
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male