MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406948
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During that atrial fibrillation cryoablation procedure, the patient experienced an air embolism.The embolism occurred after the transseptal puncture, when the physician removed the needle and the dilatator and re-inserted the guidewire into the sheath.It is thought that the air entered the sheath when the valve-pass was placed in the valve to insert the guidewire.It is possible that the valve-pass obstructed the irrigation entry of the sheath so the air was allowed into the left atrium.The procedure was stopped and the patient was placed in a hyperbaric chamber.The patient is stable.
Event or Problem Description
During that atrial fibrillation cryoablation procedure, the patient experienced an air embolism.The embolism occurred after the transseptal puncture, when the physician removed the needle and the dilatator and re-inserted the guidewire into the sheath.A bubble was seen in the heart using fluoroscopy and there was a segment of st elevation.It is thought that the air entered the sheath when the valve-pass was placed in the valve to insert the guidewire.It is possible that the valve-pass obstructed the irrigation entry of the sheath so the air was allowed into the left atrium.The procedure was stopped and the patient was placed in a hyperbaric chamber.The patient is stable.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
One 8f 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 distal face of the seal, at both ends of the seal slit.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¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• 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: 15912886
• Report Number: 3005334138-2022-00661
• Device Sequence Number: 14552281
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/17/2023

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: 08/31/2025
• Device Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 8670833
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 12/15/2022; 04/01/2023
• Initial Report FDA Received Date: 12/04/2022
• Supplement Report FDA Received Date: 12/26/2022; 12/26/2022; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: Other
• Patient Sex: Unknown