MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F; CATHETER, INTRODUCER

Model Number	406853
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the dilator that came with the sheath was straight.When the needle was advanced through the dilator, it was noted that it poked through the side of the dilator and distal part of the sheath.The sheath and dilator were exchanged, and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The dilator had been perforated proximal to the distal tip.Functional testing with a brk needle was not performed because the complaint introducer is a swartz right sided (sr series) guiding introducer dilator, not a transseptal introducer dilator.For transseptal access with a brk needle, swartz left sided (sl series) transseptal guiding introducers are recommended.The dilator had no visible curve at the distal end.However, the dilator for this device (sr series) is manufactured without a curve; therefore, no curve issues were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the dilator puncture and reported brk needle insertion difficulties is consistent with the incorrect use of the device.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F
• Common Device Name: CATHETER, INTRODUCER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17849321
• Report Number: 3005334138-2023-00442
• Device Sequence Number: 4312738
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 12/31/2025
• Device Model Number: 406853
• Device Lot Number: 8857297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/30/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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: Female
• Patient Weight: 45 KG