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

Model Number	C407699
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
While removing the sheath, the yellow cap detached and had to be held in place to prevent further blood loss.
Additional Manufacturer Narrative
One ultimum ev introducer was returned to the manufacturer for analysis.The hemostasis cap had been detached from the hemostasis body.Additional investigation revealed there was evidence that the device had been welded at the hemostasis cap and hemostasis hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the hemostasis cap detachment remains unknown.

• 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: 8437865
• Report Number: 3005334138-2019-00151
• Device Sequence Number: 16657109
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 09/11/2019

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: 08/31/2020
• Device Model Number: C407699
• Device Lot Number: 6632443
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR