MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406783
Medical Device Problem Codes	Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Perforation (2513)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a myocardiac biopsy, a tamponade occurred requiring a pericardiocentesis to stabilize the patient.Access was gained through the jugular site, the biopsies were performed and at the end of the procedure, hemodynamic compromise was observed and the patient experienced cardiac arrest.An echocardiogram was done which confirmed the perforation and a pericardiocentesis was performed and the patient stabilized.It is thought that the perforation occurred at the apex.The physician reported that the introducer was not rigid enough for such a procedure and that it was difficult to control enough while advancing through the anatomy.
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.
Event or Problem Description
Follow up report needed to include updated medical device problem a code.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• 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: 17221381
• Report Number: 3005334138-2023-00284
• Device Sequence Number: 6214150
• Product Code: DYB
• UDI-Device Identifier: 05414734012942
• UDI-Public: 05414734012942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914090
• 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): 04/10/2024

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: 11/30/2023
• Device Model Number: 406783
• Device Catalogue Number: 406783
• Device Lot Number: 7771744
• Was Device Available for Evaluation?: No
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/14/2023; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown