MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number	C407698
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
After the tavi procedure, it was noticed that the patient did not have any pulsation in the left leg.A contrast injection of the left femoral confirmed an obstruction around the femoral head.An endarterectomy was performed which went well.The patient is doing fine now and is stable.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10520484
• Report Number: 3005334138-2020-00400
• Device Sequence Number: 3203956
• Product Code: DYB
• UDI-Device Identifier: 05415067009692
• UDI-Public: 05415067009692
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 06/30/2022
• Device Model Number: C407698
• Device Catalogue Number: C407698
• Device Lot Number: 7083899
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: Required Intervention
• Patient Age: 74 YR