MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406137
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
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.Further information regarding the patient identifiers, patient consequences and physician name was requested but not received.
Event or Problem Description
The tubing of the introducer was found detached at the irrigation port of the sheath while in the patient.The patient complained of feeling "wet" and the nurse found the detached irrigation port.Pressure was applied over the dressing, the patient was placed in trendelenberg and the introducer was removed with no consequences to the patient.
Additional Manufacturer Narrative
One fast-cath hemostasis introducer was returned for analysis.The reported event of sideport tubing detachment was confirmed.The extension tubing had detached from the sideport of the hemostasis body due the stopcock tubing not being fully inserted the sideport.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8532804
• Report Number: 3005334138-2019-00215
• Device Sequence Number: 1954912
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: 05414734012751
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 09/30/2021
• Device Model Number: 406137
• Device Lot Number: 6671878
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1