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

Model Number	C408507
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacture ref: 3005334138-2023-00534.During a diagnostic cardiac cath procedure, upon removal of the device from the patient, blood was noted inside the device due to a valve issue.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Concomitant device: unknown engage introducer.
Additional Manufacturer Narrative
One 6f engage introducer sheath and dilator were received for evaluation.The sheath was tested for leaks.An aspiration vacuum leak test was conducted; air aspirated into the syringe.A pressure leak test (liquid method) was also conducted; water was noted to leak out of the hemostasis hub.Microscopic inspection of the hemostasis hub revealed the seal had been rotated onto its side; the displaced seal is consistent with the leak.The cause of the displaced seal remains unknown.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: ENGAGE 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: 18140527
• Report Number: 3005334138-2023-00533
• Device Sequence Number: 7991770
• Product Code: DYB
• UDI-Device Identifier: 05414734030465
• UDI-Public: 05414734030465
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 01/31/2026
• Device Model Number: C408507
• Device Lot Number: 8842166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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