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	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Block (4444)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation procedure, there was an air leak from the seal of the introducer resulting in st elevation, av block, and hypotension.Air was being aspirated into the left atrium.The non-abbott catheter was inserted into the introducer, there was a resistance that could be overcome with a little pressure.During the subsequent aspiration of the introducer, there was already air in the system.The airlock had already been rinsed and connected to the continuous rinsing system, which was empty of air.The patient was stabilized with 100% oxygen, rv pacing, head down position, and coronary angiography with no long-term consequences or damage.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.Functional testing confirmed an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in the proximal face of the seal and on the side wall.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leak and subsequent st elevation, av block, and hypotension remains unknown.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.Functional testing confirmed an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in the proximal face of the seal and on the side wall.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 remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15965053
• Report Number: 3005334138-2022-00658
• Device Sequence Number: 4938746
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 406853
• Device Catalogue Number: 406853
• Device Lot Number: 8452275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 01/04/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/09/2023; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown