MAUDE Adverse Event Report: SURMODICS INC SUBLIME¿ RADIAL ACCESS GUIDE SHEATH; Introducer, catheter

Model Number	SRA-GS35-6F120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The guide sheath was used during a left radial artery access procedure.During removal of the guide sheath, the patient had a significant arterial spasm.A vessel cut down and other remedies were required to remove the sheath.The procedure delay and outcome was unknown at the time of report.

• Brand Name: SUBLIME¿ RADIAL ACCESS GUIDE SHEATH
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer (Section G): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 20700466
• Report Number: 3014687026-2024-00004
• Device Sequence Number: 8101298
• Product Code: DYB
• UDI-Device Identifier: 05391525785165
• UDI-Public: 05391525785165
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: FDA PREMARKE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2025
• Device Model Number: SRA-GS35-6F120
• Device Lot Number: 22201208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female