MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8 F; INTRODUCER, CATHETER

Model Number	406706
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a sheath breakage occurred.Prior to removal of the sheath, the catheter was removed, a j-tip wire was inserted and the wire would not thread as expected.Upon removal of the wire, it was noted that it was bent.A new wire was inserted, the sheath was removed and manual pressure was applied.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.Three images were submitted for evaluation to product performance engineering; no device components were returned.The photos appeared to show an 8f fast-cath cath-lock introducer sheath.The sheath tubing appeared to be torn and separated at mid-sheath.Visual inspection was based solely upon a review of the photographs provided as the device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported sheath fracture remains unknown.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8 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: 18066582
• Report Number: 3005334138-2023-00514
• Device Sequence Number: 7759402
• Product Code: DYB
• UDI-Device Identifier: 05414734216999
• UDI-Public: 05414734216999
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 406706
• Device Lot Number: 9017433
• Was Device Available for Evaluation?: No
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 12/03/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown