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

Model Number	C408536
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the percutaneous coronary intervention procedure, the balloon was inserted into the patient and filled when a blood leak was noted.The device was replaced and the procedure was completed with no adverse consequences to the patient.
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 incident could not be conclusively determined.
Event or Problem Description
Device received for evaluation.This follow up report is needed to address updated analysis.
Additional Manufacturer Narrative
One 6f engage introducer sheath was received for evaluation.The dilator was also returned.Functional testing confirmed a fluid leak in the hemostasis valve.Further investigation revealed the hemostasis seal had been rotated on its side; the displace seal is consistent with the leak.No visual anomalies or functional anomalies were noted regarding the seal slits.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the rotated seal remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: ENGAGE TR 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: 17950138
• Report Number: 3005334138-2023-00475
• Device Sequence Number: 7623504
• Product Code: DYB
• UDI-Device Identifier: 05414734030403
• UDI-Public: 05414734030403
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093130
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: 12/31/2025
• Device Model Number: C408536
• Device Lot Number: 8864997
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 01/19/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/14/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown