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

Model Number	C408506
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the shaft of the sheath detached.The sheath was placed in femoral artery for a diagnostic heart catheterization procedure.Once it turned into an intervention, the sheath has to be up sized to a 6f.A j-wire was introduced thru the 5f sheath and in an attempt to remove it, the hub separated from the shaft.The shaft was partially outside the patient and was removed by sliding it over the wire.A 6f sheath was used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 5f engage introducer sheath was received for evaluation.Visual inspection revealed the sheath tubing had detached from the hemostasis hub.The hemostasis hub was dissected and microscopic inspection showed an aggressive header wash had thinned the header neck, consistent with the detachment.The root cause of the sheath tubing detachment is consistent with a manufacturing issue.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18932956
• Report Number: 3005334138-2024-00097
• Device Sequence Number: 17271462
• Product Code: DYB
• UDI-Device Identifier: 05414734052979
• UDI-Public: 05414734052979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/12/2024

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: 06/30/2026
• Device Model Number: C408506
• Device Catalogue Number: C408506
• Device Lot Number: 9103796
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White