MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE TR INTRODUCER; INTRODUCER, CATHETER

Model Number	C408539
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After the computed tomography coronary angiography procedure, when attempting to remove introducer, the hub and sideport detached.They managed to get it intact.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 6f engage introducer sheath was received for evaluation.The sheath tubing had been fractured and torn from the hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn sheath tubing remains unknown.

• Brand Name: ENGAGE TR 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20372563
• Report Number: 3005334138-2024-00403
• Device Sequence Number: 14374784
• Product Code: DYB
• UDI-Device Identifier: 05414734030441
• UDI-Public: (01)05414734030441(10)10058820(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K111092
• 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): 11/06/2024

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: 09/30/2026
• Device Model Number: C408539
• Device Catalogue Number: C408539
• Device Lot Number: 10058820
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown