MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; Introducer, catheter

Model Number	406849
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of skiving could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During the ablation procedure, after the transseptal puncture the needle was removed and a piece of plastic was seen at the tip, presumably sheared off from the inside of the dilator.The sheath and needle were both replaced and the procedure was completed with no adverse consequences to the patient.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.
• 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: 23547021
• Report Number: 3005334138-2025-00691
• Device Sequence Number: 9448566
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• 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
• Report Date (Section B): 11/13/2025

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: 406849
• Device Catalogue Number: 406849
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown