MAUDE Adverse Event Report: Abbott Medical STEERABLE GUIDE CATHETER; Catheter, Steerable

Model Number	SGC0301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.During the procedure, the steerable guide catheter (sgc) was advanced on the guidewire.While advancing the sgc through the peripheral venous access, the guidewire became kinked.The sgc then perforated the iliac vein and the procedure was discontinued.The patient was transferred and successfully underwent the implantation of a covered stent in the iliac vein.The patient was stabilized.There were no mitraclips implanted, the mr remained at grade 4+.There were no clinically significant delays reported.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• Brand Name: STEERABLE GUIDE CATHETER
• Common Device Name: Catheter, Steerable
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50147394
• Report Number: 2135147-2026-05334
• Device Sequence Number: 13113523
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)270312(10)60311R1060
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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 Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 60311R1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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; Required Intervention
• Patient Sex: Unknown