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

Model Number	C408502
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the side port detached and a blood leak occurred, when the upper sheath catheter was placed in the popliteal fossa of the left knee.The procedure was completed by replacing the device without any further patient consequences.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported material separation and subsequent leak could not be conclusively determined.
Additional Manufacturer Narrative
One 6f engage introducer sheath was received for evaluation.The hemostasis hub had been fractured and detached at its proximal end; the detached section was returned.It was noted that the green hemostasis cap remained welded to the detached section of the hemostasis hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fluid leak is consistent with the hemostasis hub fracture.The cause of the hemostasis hub fracture remains unknown.
Additional Manufacturer Narrative
Additional information revealed the initial and final mdr for this event was reported under the incorrect mfr report #.The correct mfr number is 3005334138.

• 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: 14548272
• Report Number: 2182269-2022-00029
• Device Sequence Number: 5007614
• Product Code: DYB
• UDI-Device Identifier: 05414734052818
• UDI-Public: 05414734052818
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 04/30/2024
• Device Model Number: C408502
• Device Catalogue Number: C408502
• Device Lot Number: 7939861
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 09/07/2022; 08/28/2024
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/29/2022; 09/09/2022; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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