MAUDE Adverse Event Report: ABBOTT MEDICAL STEERABLE GUIDE CATHETER; CATHETER, STEERABLE

Model Number	SGC0301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/08/2025
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 that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, thin leaflets, and suboptimal transseptal puncture.A steerable guide catheter (sgc) was inserted without issues.However, during dilator removal of the sgc, a leak was observed, and imaging revealed air in the left chamber.Aspiration was performed.A decision was made to remove and replace the sgc.A new sgc was inserted, and the procedure was continued.One clip was implanted, reducing mr to trace.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
All available information was investigated, and the reported leak (loss of fluid column) was not confirmed via returned device 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.The investigation was unable to determine a cause for the reported leak.The reported patient effect of air embolism appears to be related to the reported leak.Air embolism is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance as additional aspiration was performed.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, thin leaflets, and suboptimal transseptal puncture.A steerable guide catheter (sgc) was inserted without issues.However, during dilator removal of the sgc, a leak was observed, and imaging revealed air in the left chamber.Aspiration was performed.A decision was made to remove and replace the sgc.A new sgc was inserted, and the procedure was continued.One clip was implanted, reducing mr to trace.There was no clinically significant delay in the procedure.

• 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: 22938451
• Report Number: 2135147-2025-04930
• Device Sequence Number: 21312264
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)260227(10)50227R2038
• 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): 10/27/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 50227R2038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown