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

Model Number 406103

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2022

Event Type  Injury  

Event Description

During a tranacatheter aortic valve replacement (tavr) procedure, the sutures were removed and when the sheath was pulled, only the hub of the device was removed.An x-ray confirmed the sheath remained in the femoral vein.The patient was brought to interventional radiology and the sheath was removed without issue.

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.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Type of Device: 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: 15200411
• MDR Text Key: 297614095
• Report Number: 3005334138-2022-00450
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: 05414734013772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 8493480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 75 KG