MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406137
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
When starting a pulmonary vasoreactivity test with dose escalation of nitroprusside, which is administered through the lumen of a swartz introducer, the patient reported pain at the insertion site of the introducer, at the right jugular.Infiltration of medication was evident.Measurements were suspended and when removing the introducer, a crack was observed in the medical device.
Additional Manufacturer Narrative
The device was not returned.One image was submitted to product performance engineering.The following visual inspection was based solely upon a review of the image provided.The sheath shaft appeared torn just distal to the sheath hub.The cause of the observed tear remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19507016
• Report Number: 3005334138-2024-00204
• Device Sequence Number: 3405044
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: (01)05414734012751(10)9166607(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K914090
• 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): 08/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 9166607
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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