MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; INTRODUCER, CATHETER

Model Number	407436
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the needle punctured the sheath.When advancing the needle through the dilator, the needle did advance through the tip.The needle was pulled back, and then the sheath and dilator were removed from the patient.It was noted that the needle had punctured through the dilator with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The dilator had been perforated proximal to the distal tip.A needle/stylet assembly from current abbott inventory was inserted and advanced through the dilator/sheath assembly; needle resistance was noted at the point of perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the perforation remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21160747
• Report Number: 3005334138-2025-00035
• Device Sequence Number: 12891887
• Product Code: DYB
• UDI-Device Identifier: 05414734203647
• UDI-Public: (01)05414734203647(10)10506308(17)270831
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K964518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 407436
• Device Catalogue Number: 407436
• Device Lot Number: 10506308
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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