MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿¿ SR SERIES, SR0¿ 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
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 ablation procedure a blood leak occurred.A blood leak was noted from the hemostasis valve during ablation with a livewire catheter.A new sheath set was used to complete the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in the side of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak is consistent with damage during use.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿¿ SR SERIES, SR0¿ 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8587064
• Report Number: 3005334138-2019-00253
• Device Sequence Number: 2293947
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 05/31/2019
• Device Model Number: 406853
• Device Lot Number: 5541346
• 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: 04/22/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1