MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406840
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation, evidence of skiving was observed.After the needle for the transseptal puncture had been inserted through the dilator of the sheath and withdrawn, the guidewire could no longer be advanced through the dilator.After removing the sheath and dilator from the patient, the physician attempted to force the wire through the dilator again, and small plastic particles emerged.The sheath was replaced and the procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.Resistance was noted near the distal end of the dilator when a brk needle/stylet assembly from current inventory was advanced through the returned dilator and sheath.The dilator tubing was cut lengthwise and a build-up of skived material was noted at the distal end of the dilator.No resistance or other functional anomalies were noted during guidewire insertion through the dilator.The dilator distal tip inside diameter measurement was consistent with manufacturing specifications.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the skiving remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• 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: 23927136
• Report Number: 3005334138-2025-00801
• Device Sequence Number: 9041418
• Product Code: DYB
• UDI-Device Identifier: 05414734203340
• UDI-Public: (01)05414734203340(10)10653416(17)271130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/03/2026

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: 406840
• Device Catalogue Number: 406840
• Device Lot Number: 10653416
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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