MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407454
Medical Device Problem Codes	Difficult to Insert (1316); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, a sheath puncture occurred.The brk needle with stylet did not fit through the sl1 sheath and the needle punctured the sheath on its distal side.Another sheath was used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath and dilator were received for evaluation.Visual inspection revealed the dilator was perforated at 1.28¿ proximal to the distal tip and the sheath soft grey tip was perforated at 0.05¿ proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported sheath perforation remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 81 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: 17481967
• Report Number: 3005334138-2023-00347
• Device Sequence Number: 7181872
• Product Code: DYB
• UDI-Device Identifier: 05414734205788
• UDI-Public: 05414734205788
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/01/2023

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: 407454
• Device Lot Number: 8841269
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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