MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER, SL1¿ 10F; Introducer, catheter

Model Number	406969
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 10f fast-cath introducer sheath and dilator were received for evaluation.The sheath tubing had been stretched and punctured in one location within the manufactured curve.The shape of the puncture material was consistent with the shape of the dilator distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The damage to the sheath is consistent with forcible contact between the dilator and the inner diameter of the sheath during dilator insertion.The cause of the device damage and forcible contact remains unknown.
Event or Problem Description
This report is to advise of a material puncture found in the sheath during analysis.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER, SL1¿ 10F
• 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: 23601649
• Report Number: 3005334138-2025-00701
• Device Sequence Number: 9978631
• Product Code: DYB
• UDI-Device Identifier: 05414734203579
• UDI-Public: (01)05414734203579(10)8545329(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/19/2025

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 Expiration Date: 05/31/2025
• Device Model Number: 406969
• Device Catalogue Number: 406969
• Device Lot Number: 8545329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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