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

Model Number	406137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Sidearm of sheath had become disconnected from the hub on the sheath.
Additional Manufacturer Narrative
The failure mode of stopcock detachment was confirmed based on the images provided, however it could not be confirmed to be use-related, manufacturing or design-related as the product was not returned for evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
During a procedure the sideport was noted to be detached from the introducer.The sheath was replaced to complete the procedure.There were no adverse consequences to the patient.

• 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: 8391294
• Report Number: 3005334138-2019-00114
• Device Sequence Number: 1628874
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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 Catalogue Number: 406137
• Device Lot Number: 6671878
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1