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

Model Number	C408508
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the sideport of the device detached.After placing a 5f catheter through the sheath, the sideport of the introducer detached.The introducer was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 7f engage introducer sheath was received for evaluation.The reported event of ¿the sideport of the device detached¿ could not be confirmed.No visual anomalies were noted on the returned sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event ¿the sideport of the device detached¿ remains unknown.

• Brand Name: ENGAGE INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12342685
• Report Number: 3005334138-2021-00503
• Device Sequence Number: 11746434
• Product Code: DYB
• UDI-Device Identifier: 05414734053013
• UDI-Public: 05414734053013
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 03/31/2023
• Device Model Number: C408508
• Device Catalogue Number: C408508
• Device Lot Number: 7457596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1