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	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The 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 leak could not be conclusively determined.
Event or Problem Description
During the transcatheter aortic valve implantation (tavi) procedure, a blood leak was noted at the valve of the introducer.The patient experienced low value of hemoglobin, but no intervention was performed.The procedure was completed with no patient consequences.

• 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: 8682425
• Report Number: 3005334138-2019-00299
• Device Sequence Number: 11327124
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 06/10/2019

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: 12/31/2020
• Device Model Number: C407699
• Device Lot Number: 6812503
• 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: 05/20/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR