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

Model Number	SGC0301
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 12 july 2026, a patient presented with grade 4+ functional mitral regurgitation (mr) and an enlarged atrium for a mitraclip procedure.During the procedure, when the steerable guide catheter (sgc) was advanced within the interatrial septum into the left atrium, air bubbles were visualized within the left atrium on echocardiography.The patient presented with st-segment elevation and an air embolism was believed to have occurred but was unable to be visualized.The sgc was removed from the patient and the patient stabilized.A replacement sgc was selected and advanced successfully and three mitraclips were implanted successfully.The procedure was discontinued, the final mr was reduced to grade 1+.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (mr) and an enlarged atrium for a mitraclip procedure.During the procedure, when the steerable guide catheter (sgc) was advanced within the interatrial septum into the left atrium, air bubbles were visualized within the left atrium on echocardiography.The patient presented with st-segment elevation and an air embolism was believed to have occurred but was unable to be visualized.The sgc was removed from the patient and the patient stabilized.A replacement sgc was selected and advanced successfully and three mitraclips were implanted successfully.The procedure was discontinued, the final mr was reduced to grade 1+.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported air in the device was unable to be determined.The reported unexpected medical intervention was due to case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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: 50122045
• Report Number: 2135147-2026-05285
• Device Sequence Number: 10480561
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)270123(10)60123R1007
• 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): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 60123R1007
• 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: 07/12/2026
• Supplement Date Received by Manufacturer: 09/05/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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
• Patient Sex: Unknown