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

Model Number	407847
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The ultimum hemostasis introducer experienced back flow of blood and leaked excessively from the valve onto the sterile drape.Allegedly this occurred multiple times over the past few weeks.Another ultimum hemostasis introducer of a different batch was used successfully.
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.The ultimum hemostasis introducer sheath instructions for use (ifu) states damage to the valve assembly may occur if the inner catheter is withdrawn rapidly.The ultimum hemostasis introducer sheath instructions for use (ifu) instructs the user to insert the dilator into hemostasis valve and then follow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 ifu cautions the user to withdraw components slowly (withdraw the needle slowly from the dilator and withdraw the dilator slowly from the sheath) to minimize the vacuum created during withdrawal.All air should be aspirated slowly from the sheath using a syringe attached to one of the side ports of the three-way stopcock.Also the dilator, sheath, and catheter should be frequently flushed with saline to minimize the potential for air emboli.

• 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: 7928152
• Report Number: 3005334138-2018-00349
• Device Sequence Number: 19194870
• Product Code: DYB
• UDI-Device Identifier: 05414734008969
• UDI-Public: 05414734008969
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K001346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 06/30/2021
• Device Model Number: 407847
• Device Catalogue Number: 407847
• Device Lot Number: 6542475
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Weight: 73