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

Model Number	406103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of a transcatheter aortic valve replacement (tavr) procedure, the device detached and a portion remained in the patient requiring additional intervention.Anesthesia inserted a central venous line at the right internal jugular and interventional cardiologist placed a temporary pacemaker through the line, and the procedure was completed.At the end of the procedure, infiltration was noted at the access site and it was decided to remove the sheath.Upon removal of the sheath, it separated leaving approximately 9cm of the sheath in the patient.Using fluoroscopy, an interventional cardiologist went through the groin and retrieved the detached portion of the device.A venous ultrasound was performed which confirmed there was no additional harm to the patient.
Additional Manufacturer Narrative
Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3005334138.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 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 detachment remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17058769
• Report Number: 2182269-2023-00026
• Device Sequence Number: 21017525
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: 05414734013772
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 08/20/2023

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: 02/28/2026
• Device Model Number: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 8920114
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/09/2023; 06/09/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/13/2023; 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White