MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 90, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407358
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, skiving occurred.Insertion difficulties were noted while advancing the needle into the sheath into the patient.The sheath and needle were removed and tested on the bench by pushing against the resistance, the needle sheared off a section of the plastic.The same bench-top testing was performed with the second sheath and needle, and the same issue was noted.The issue was eventually resolved, and the procedure was completed with no adverse patient health consequences.There has been no suggestion that any plastic was dislodged in the patient's circulation.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath and dilator were received for evaluation.No anomalies were noted when a brk needle/stylet assembly was advanced through the returned sheath/dilator assembly.The dilator was dissected, and no evidence of skiving was noted.Information reported from the field indicated that the returned device was used with a needle that was re-shaped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.A brk transseptal needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the cause of the reported issue is consistent with not following the instructions for use.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 one 8.5f swartz braided introducer sheath and dilator were received for evaluation.No anomalies were noted when a brk needle/stylet assembly was advanced through the returned sheath/dilator assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The brk transseptal needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the cause of the reported event is consistent with not following the instructions for use.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 90, 63 CM LENGTH, 8.5F
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18616532
• Report Number: 3005334138-2024-00041
• Device Sequence Number: 7509471
• Product Code: DYB
• UDI-Device Identifier: 05414734205535
• UDI-Public: 05414734205535
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052644
• 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,Followup
• Report Date (Section B): 04/22/2024

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: 09/30/2026
• Device Model Number: 407358
• Device Lot Number: 10014585
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 04/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/07/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: Unknown