MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406128
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During cardiomems implant procedure, the physician was unable to remove the sheath which caused a delay.The physician could not separate the sheath, wire, and cardiomems devices from each other.During the cardiomems implant, the wire did not have the support to bring the cardiomems sensor to the pulmonary artery.The physician tried to pull the device back through the sheath, but it folded onto itself.The physician determined that the sheath and device could not be safely removed.A significant delay was reported while the physician was deciding an action plan and waiting for vascular surgery to arrive.Vascular surgery was called and they were able to pull the sheath out, but the cmems device remained in the soft tissue.Vascular surgery was able to do a small cut down and removed the cardiomems device.The patient had a perclose in place and that was utilized.Patient remained stable throughout the entire procedure.The patient remained stable throughout the entire procedure.The patient was discharged and not hospitalized following the procedure.There were no post-procedure complications, but the physician reported there to be a significant delay due to deciding the plan of action and waiting for the vascular team to arrive.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.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 removal difficulties and subsequent delay remains unknown.

• Brand Name: FAST-CATH¿ HEMOSTASIS 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: 21211058
• Report Number: 3005334138-2025-00058
• Device Sequence Number: 3851846
• Product Code: DYB
• UDI-Device Identifier: 05414734008280
• UDI-Public: (01)05414734008280(10)8556530(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• 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): 05/19/2025

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: 406128
• Device Catalogue Number: 406128
• Device Lot Number: 8556530
• Was Device Available for Evaluation?: No
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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 Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG