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

Model Number	SGC0301
Medical Device Problem Codes	Positioning Failure (1158); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 on a patient with an enlarged atrium.A steerable guide catheter (sgc) was prepared and inserted.However, to achieve a better trajectory, additional ¿+¿ knob was applied, and after applying ¼ ¿+¿, resistance was encountered.Troubleshooting was performed, but the knob would still not work.Therefore, the sgc was removed and replaced.A new sgc was inserted and the procedure was continued.A mitraclip xtr was inserted and deployed on the valve.However, during deployment, the clip suddenly opened from roughly to degrees to roughly 70 degrees.The clip was reported to be stable on the leaflets.The procedure was then discontinued, and the mr increased to a grade of 4+.There was no clinically significant delay in the procedure.The patient was then transferred to surgery for mitral valve replacement.The patient was reported to be recovering.The steerable guide catheter (sgc) device returned and analysis performed on (b)(6)2026 revealed a cable break.
Additional Manufacturer Narrative
The device has been received.However, investigation is not yet complete.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: 50693835
• Report Number: 2135147-2026-06078
• Device Sequence Number: 21231398
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• 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
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 51216R1016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 123 LB