MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F; Introducer, catheter

Model Number	407439
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath was received for evaluation.The sheath had been perforated proximal to the distal tip.The sheath was 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 needle insertion difficulty and perforation remains unknown.
Event or Problem Description
This report is to advise of a puncture found in the sheath during analysis.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F
• 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: 19492173
• Report Number: 3005334138-2024-00224
• Device Sequence Number: 17901602
• Product Code: DYB
• UDI-Device Identifier: 05414734205634
• UDI-Public: (01)05414734205634(10)10118430(17)261231
• 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
• Report Date (Section B): 06/06/2024

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 Model Number: 407439
• Device Lot Number: 10118430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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