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

Model Number	407843
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After the puncture was performed, the catheter was placed inside the sheath, and the valve was leaking blood.Another sheath was used to continue and complete the procedure with no patient consequences.
Additional Manufacturer Narrative
The reported event of a leak could not be confirmed.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9224553
• Report Number: 3005334138-2019-00581
• Device Sequence Number: 177800
• Product Code: DYB
• UDI-Device Identifier: 05414734011051
• UDI-Public: 05414734011051
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K001346
• 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): 11/12/2019

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: 07/31/2021
• Device Model Number: 407843
• Device Catalogue Number: 407843
• Device Lot Number: 6609134
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 70