MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ULTIMUM; INTRODUCER, CATHETER

Model Number	407849
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
When accessing veins in groin, 8 fr sheath broke off in patient's right femoral vein.Vascular surgeon came in to snare and remove broken sheath successfully.

• Brand Name: ULTIMUM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12238109
• Report Number: 12238109
• Device Sequence Number: 19876940
• Product Code: DYB
• UDI-Device Identifier: 05414734011099
• UDI-Public: (01)05414734011099
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021
• Report Date (Section F): 07/19/2021

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 Model Number: 407849
• Device Catalogue Number: 407849
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Date Report Sent to FDA: 07/19/2021