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

Model Number	C408507
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of a diagnostic catheterization procedure, while attempting routine sheath removal from the right femoral artery, the device separated into two pieces.The sheath broke apart just under the hemostatic valve of the sheath resulting in significant bleeding.Pressure was applied and a hemostat was applied to the exposed sheath piece.Upon the physician's arrival the patient was awake and talking but mildly hypotensive.While maintaining hemostasis with direct pressure, the remainder of the sheath was removed from the arteriotomy uneventfully.Manual pressure was applied to the arteriotomy as usual.
Additional Manufacturer Narrative
One 6f engage introducer sheath was received for evaluation.The sheath hub was noted to be detached from the sheath shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath hub separation from the sheath shaft remains unknown.

• 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19638913
• Report Number: 3005334138-2024-00256
• Device Sequence Number: 8610356
• Product Code: DYB
• UDI-Device Identifier: 05414734030465
• UDI-Public: (01)05414734030465(10)10120323(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Model Number: C408507
• Device Catalogue Number: C408507
• Device Lot Number: 10120323
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White