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 Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.During the procedure, one mitraclip was successfully implanted at anterior and posterior leaflet 2(a2p2).During deployment of second mitraclip, air ingression was observed from hemostasis valve of steerable guide catheter (sgc).Air embolism was formed in the blood vessel.Hypotension and elevation in st segment was observed along with myocardial infraction.Medication was administered to control hypotension and st elevation.The mr was reduced to grade 1+ post procedure.There was no clinically significant delay.
Additional Manufacturer Narrative
In this case, there was no functional testing for the returned device as no device malfunction was reported.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation was unable to determine a cause for the reported air embolism.The reported myocardial infarction (mi), non specific ekg/ecg (elevation in st segment) changes, and hypotension were cascading effects of the air embolism.Air embolism, myocardial infarction (mi), non specific ekg/ecg changes, and hypotension are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance as the pericardiocentesis was performed.The reported medication required was a result of case specific circumstance as medication was administered to control hypotension and st elevation.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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 ; 6517565400
• MDR Report Key: 23855968
• Report Number: 2135147-2025-07577
• Device Sequence Number: 13297931
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)260527(10)50527R1034
• 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): 01/22/2026

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 Expiration Date: 05/27/2026
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 50527R1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP; STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Female