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

Model Number	C407699
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The images submitted appeared to show damage to the hemostasis cap, which was detached from the sheath, and a bls on/in the device.The device history record (dhr) was reviewed to ensure that each manufacturing and inspection operation was performed.The dhr review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
Towards the end of the tavi procedure, while the delivery system was being removed from the patient, through a 19f ultimum sheath, the introducer¿s valve that prevents back flow of blood broke.There was bleeding from the femoral artery.The problem was identified and the bleeding was stopped by applying manual pressure and inserting a new sheath.A hematoma developed in the access site, which resolved with 20 minutes of manual pressure post procedure.

• 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: 8273845
• Report Number: 3005334138-2019-00037
• Device Sequence Number: 1557391
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140327
• 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
• Report Date (Section B): 01/24/2019

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: 07/31/2020
• Device Model Number: C407699
• Device Lot Number: 6578859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR