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	10/23/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade mitral regurgitation for a mitraclip procedure.During the procedure, a steerable guide catheter (sgc) was advanced into the left atrium when air was identified at the proximal end of the sgc during negative pressure suction while withdrawing the dilator and guidewire.At this time, the patient experienced a myocardial infraction believed to be caused by a potential air embolism.The sgc was removed from the patient and the procedure was discontinued.The final mr was grade.There were no clinically significant delays were reported.
Event or Problem Description
N/a.
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 other 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 serious injury/illness/impairment was a result of case specific circumstance as no additional intervention or treatment was provided.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 23547732
• Report Number: 2135147-2025-06589
• Device Sequence Number: 9327019
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)260401(10)50331R1013
• 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): 01/14/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 50331R1013
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: Other
• Patient Sex: Unknown