MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F; INTRODUCER, CATHETER

Model Number	406701
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a introducer fracture found during analysis.
Additional Manufacturer Narrative
One 6f fast-cath introducer sheath was received for evaluation.The sheath tubing had been cut and also stretched and torn into three sections; all three sections were returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing damage remains unknown.
Additional Manufacturer Narrative
The physician's name is dr.(b)(6).

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 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: 15373375
• Report Number: 3005334138-2022-00505
• Device Sequence Number: 19231998
• Product Code: DYB
• UDI-Device Identifier: 05414734216944
• UDI-Public: 05414734216944
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 05/31/2023
• Device Model Number: 406701
• Device Catalogue Number: 406701
• Device Lot Number: 7555533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 09/11/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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