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

Model Number	407832
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the hub of the ultimum hemostasis introducer came apart.
Additional Manufacturer Narrative
One ultimum hemostasis introducer was returned for evaluation.Visual inspection revealed the dilator tube was separated from the dilator hub, and indentations were present at the distal tip.Further investigation revealed the dilator tubing was not positioned into the hub the correct distance allowing for a weak joint where the tubing detached from the hub.As a result of this finding, abbott is performing further investigation.
Event or Problem Description
During the procedure, the hub of the ultimum hemostasis introducer detached.Procedure was finished without a new device and no patient consequences.

• 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: 8346300
• Report Number: 3005334138-2019-00065
• Device Sequence Number: 16721113
• Product Code: DYB
• UDI-Device Identifier: 05414734008822
• UDI-Public: 05414734008822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/21/2019

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: 10/31/2021
• Device Model Number: 407832
• Device Catalogue Number: 407832
• Device Lot Number: 6723891
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 06/13/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/05/2019; 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1