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

Model Number	407845
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A st jude ultimum 6f sheath was opened for placement in the patient's femoral artery; the patient was undergoing cardiac catheterization.The introducer, included in the packaging with the sheath, could not be introduced into the sheath (through the proximal diaphragm at the hub).Upon further inspection, it was noted the distal end was not tapered as intended but instead blunt.The sheath was removed from the field and another sheath was opened and utilized.The inventory, within the cath lab, was inspected and all other sheaths with the lot number of this device appeared to be tapered.

• 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: 8481969
• Report Number: 8481969
• Device Sequence Number: 1471156
• Product Code: DYB
• UDI-Device Identifier: 05414734011075
• UDI-Public: (01)05414734011075
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/25/2019
• Report Date (Section F): 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 407845
• Device Catalogue Number: 407845
• Device Lot Number: 6751025
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/25/2019