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

Model Number	406354
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient began to receive ecmo continuous treatment to maintain cardiopulmonary function, and the superficial femoral artery collateral of the right lower extremity was implanted with a fast-cath hemostasis introducer.Blood was flowing out from the head of the sheath.After inspection, the white part of the sheath was found to be cracked.Immediately replaced a new sheath, re-inserted the catheter into the superficial femoral artery side of the right lower extremity.There was a small amount of bleeding during the catheterization process, which caused secondary injury to the patient.
Additional Manufacturer Narrative
Additional information: d9.G3.H2, h3 one 6f fast-cath introducer sheath was received for evaluation.The sheath hemostasis hub had been fractured and detached at its proximal end; the detached section, cap and hemostasis seal were not returned.There were multiple bends throughout the sheath tubing and a suture was tied to the sheath 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.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17079825
• Report Number: 3005334138-2023-00242
• Device Sequence Number: 6345917
• Product Code: DYB
• UDI-Device Identifier: 05414734013000
• UDI-Public: 05414734013000
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Device Model Number: 406354
• Device Catalogue Number: 406354
• Device Lot Number: 7787832
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown