MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number	407455
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the needle did not advance as expected into the sheath.Upon removal from the patient, it was noted that the needle had pushed into the side wall.The sheath was replaced with no consequences to the patient.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer dilator was received for evaluation.The dilator had been perforated proximal to the distal tip.The dilator and a stock sheath were flushed with fluid and the dilator was inserted into the sheath; no resistance or anomalies were noted.A needle/stylet assembly from current inventory was inserted and advanced through the dilator/sheath assembly; however, the needle could not advance past the location of the perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the puncture remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2¿, 63 CM LENGTH, 8.5 F
• 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: 18084885
• Report Number: 3005334138-2023-00517
• Device Sequence Number: 7692725
• Product Code: DYB
• UDI-Device Identifier: 05414734205795
• UDI-Public: 05414734205795
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 07/31/2026
• Device Model Number: 407455
• Device Lot Number: 9196812
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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