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	06/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The valve on the ultimum hemostasis introducer was defective and the device leaked.
Event or Problem Description
The valve on the ultimum hemostasis introducer was defective during the procedure and the device leaked at the valve.Another ultimum hemostasis introducer was used.The procedure time was doubled.
Additional Manufacturer Narrative
The reported event of leak could not be confirmed.The results of the investigation concluded that the hemostasis sheath passed pressure and aspiration leak testing with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.The ultimum hemostasis introducer sheath instructions for use (ifu) instructs the user to insert the dilator into hemostasis valve and then follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator and hemostasis introducer use.The ultimum hemostasis introducer sheath instructions for use (ifu) states that prior to proceeding, verify the hemostasis introducer is of proper size to allow passage of desired catheter or other medical device.The ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.
Event or Problem Description
No patient specific information has been provided by the hospital.

• 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: 7746748
• Report Number: 3005334138-2018-00225
• Device Sequence Number: 1318996
• Product Code: DYB
• UDI-Device Identifier: 05414734011051
• UDI-Public: 05414734011051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 09/19/2018

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: 02/28/2021
• Device Model Number: 407843
• Device Catalogue Number: 407843
• Device Lot Number: 6372050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/29/2018; 08/30/2018; 09/17/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/29/2018; 09/06/2018; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1