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

Model Number	C408507
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the peripheral angiogram procedure, it was noted that the sheath separated from the hub while it was being removed from the patient.No interventions were required to remove the sheath.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One 6f engage introducer sheath was received for evaluation.The dilator was also returned.The sheath tubing had been torn and stretched into two sections; both sections were returned; the distal section had been torn, stretched and detached from the sheath hub; the proximal section had been torn and stretched and remained inside the hemostasis hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the ¿sheath separated from the hub¿ 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15912719
• Report Number: 3005334138-2022-00659
• Device Sequence Number: 6722934
• Product Code: DYB
• UDI-Device Identifier: 15414734030462
• UDI-Public: 05414734030465
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2022

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: 06/30/2025
• Device Model Number: C408507
• Device Catalogue Number: C408507
• Device Lot Number: 8524822
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/04/2022
• Supplement Report FDA Received Date: 12/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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