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 Code	Cardiac Arrest (1762)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6)2026, a patient presented with grade 4 functional mitral regurgitation (mr), restricted posterior leaflet for a mitraclip procedure.During the procedure, physician inserted steerable guide catheter (sgc) into the left atrium.After confirming that there was no problem, guide wire and dilator was removed.Physician pumped the blood that had been extracted under negative pressure back into the left atrium.During the rinsing process of clip delivery system (cds), physician noticed that the patient's heart had stopped beating.After a brief external cardiac compression, the patient's heart resumed beating.Sgc was removed and procedure was discontinued.Patient was moved to intensive care unit.The final mr was grade 4.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), restricted posterior leaflet for a mitraclip procedure.During the procedure, physician inserted steerable guide catheter (sgc) into the left atrium.After confirming that there was no problem, guide wire and dilator was removed.Physician pumped the blood that had been extracted under negative pressure back into the left atrium.During the rinsing process of clip delivery system (cds), physician noticed that the patient's heart had stopped beating.After a brief external cardiac compression, the patient's heart resumed beating.Sgc was removed and procedure was discontinued.Patient was moved to intensive care unit.The final mr was grade 4.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.Based on available information, the cause of cardiac arrest was unable to be determined.The reported patient effects of cardiac arrest is listed in the mitraclip system instructions for use, is known possible complications associated with mitraclip procedures.The reported unexpected medical intervention were results of 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: 50020378
• Report Number: 2135147-2026-05100
• Device Sequence Number: 21477564
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)270312(10)60311R1053
• 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): 08/25/2026

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 Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 60311R1053
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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: Disability; Required Intervention
• Patient Sex: Unknown