MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES 8.5F; INTRODUCER, CATHETER

Model Number	406857
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The sideport detached from the sheath.The sheath was replaced to complete the procedure and there were no patient consequences.
Additional Manufacturer Narrative
The reported event of ¿the sheath was broken¿ was confirmed.The hemostasis hub had been detached from the tubing of the sheath consistent with the reported event.Dissection of the hemostasis hub revealed the header wash was formed properly and met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached hemostasis hub remains unknown.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7876203
• Report Number: 3005334138-2018-00318
• Device Sequence Number: 2076320
• Product Code: DYB
• UDI-Device Identifier: 05414734203029
• UDI-Public: 05414734203029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061015
• 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): 11/07/2018

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: 01/31/2020
• Device Model Number: 406857
• Device Lot Number: 5874903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 10/23/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 09/14/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1