MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	407847
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, when removing the sheath sheered 1 cm distal from the hub.Ultrasound was used to identify the right femoral vein, proximal to the bifurcation.A seldinger needle was introduced into the vessel and the vessel was aspirated, after aspiration a guide wire was introduced into the needle.After guide wire placement, an 11 blade was used to lance the skin at the junction of the wire with the blade facing laterally.A 7 fr and 8.5 fr short sheath were then passed over the wire into the vessel.Both passed smoothly and without resistance.The dilator and wire were then removed from the sheath hub, with a left hand placed on the hub to stabilize while the right hand applied light downward pressure to disconnect the sheath from the hub.At the conclusion of the case, the short sheaths were pulled with gentle traction distally.The 7 fr sheath sheered 1 cm distal from the hub.This portion of sheath would have been within the soft tissue during the case.An interventional radiologist removed the remainder of the sheath from patient which added 2.5 hours to the procedure.The patient is stable.
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.

• Brand Name: ULTIMUM 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17499493
• Report Number: 3005334138-2023-00351
• Device Sequence Number: 19431650
• Product Code: DYB
• UDI-Device Identifier: 05414734008969
• UDI-Public: 05414734008969
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K031137
• 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): 08/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 407847
• Device Lot Number: 8676728
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male