MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, 12F, 40CM; INTRODUCER, CATHETER

Model Number	406961
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	04/18/2019
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. .
Event or Problem Description
Following an atrial flutter procedure, the triple valve had detached from the hub of the sheath while being removed from the patient.The procedure had been successfully completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One fast-cath hemostasis introducer, 12f, 40cm was returned for investigation.The sheath had been stretched and the sheath tube detached from the hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the stretched sheath and sheath detachment is consistent with damage during use.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, 12F, 40CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8611694
• Report Number: 3005334138-2019-00264
• Device Sequence Number: 11183904
• Product Code: DYB
• UDI-Device Identifier: 05414734204026
• UDI-Public: 05414734204026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 07/31/2021
• Device Model Number: 406961
• Device Lot Number: 6601142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1