MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿TRIO INTRODUCER, 10F, ACT; INTRODUCER, CATHETER

Model Number	406963
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	07/19/2019
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
During an atrial fibrillation procedure, one of the hemostasis valves detached from the sheath.A non-abbott introducer was inserted through the valve at the time.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event of a hemostasis valve detaching was confirmed.The blue hemostasis hub was detached and additional analysis revealed insufficient adhesive was noted on the middle port of the adapter and the interior of the blue hemostasis hub, consistent with the detached hemostasis hub.

• Brand Name: FAST-CATH¿TRIO INTRODUCER, 10F, ACT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8865320
• Report Number: 3005334138-2019-00431
• Device Sequence Number: 14141841
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: 05414734204057
• 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): 01/10/2020

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: 12/31/2021
• Device Model Number: 406963
• Device Lot Number: 6830147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1