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	Unspecified Tissue Injury (4559)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, the steerable guide catheter (sgc) caused tissue damage to the chiari network.A mitraclip was successfully implanted and the procedure was discontinued.The final mr was grade 4.There were no clinically significant delays reported.
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.
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.The investigation determined the reported tissue injury appears to be related to procedural conditions.Tissue injury 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 no intervention/treatment was provided for the tissue injury.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: 23924382
• Report Number: 2135147-2025-07822
• Device Sequence Number: 18395512
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)260731(10)50730R2020
• 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): 03/10/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 50730R2020
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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 Age: 63 YR
• Patient Sex: Female