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

Model Number	406963
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, and air leak occurred.After placing the sheath, and prior to inserting catheters into the sheath, air was aspirated into a syringe that connected to the extension port of one of the ports.Several aspirations were attempted but the air was still aspirated.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10f fast-cath trio introducer sheath was received for evaluation.The dilator and guidewire assembly were also received. functional testing confirmed air had aspirated into the syringe.A pressure leak test (liquid method) was also conducted; water was noted to leak out of the sheath hub/adapter connection.It was noted that the air leak and fluid leak locations were visible at the sheath hub/adapter connection.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11944650
• Report Number: 3005334138-2021-00336
• Device Sequence Number: 11766162
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: 05414734204057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/08/2021

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: 03/31/2023
• Device Model Number: 406963
• Device Catalogue Number: 406963
• Device Lot Number: 7466669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• 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: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/06/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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
• Patient Sex: Unknown