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

Model Number	SGC0301
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) and prolapsed anterior leaflet.A mitraclip xtw inserted and was deployed on the mitral valve, reducing mr to trace.On (b)(6) 2025, one week post implant, an echocardiogram was performed and revealed recurrent mr with a grade of 4+.It was noted that the clip remained stable on the leaflets.A mitraclip xtr was inserted and deployed on the mitral valve, reducing mr to a grade of 1.The steerable guide catheter (sgc) returned and revealed damage to the soft tip and braded shaft.
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.
Additional Manufacturer Narrative
All available information was investigated.There were no reported issues to test for, but a deformed soft tip and braided shaft were observed.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, a cause of the reported no apparent adverse event could not be determined as there was no patient adverse event.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) and prolapsed anterior leaflet.A mitraclip xtw inserted and was deployed on the mitral valve, reducing mr to trace.On (b)(6) 2025, one week post implant, an echocardiogram was performed and revealed recurrent mr with a grade of 4+.It was noted that the clip remained stable on the leaflets.A mitraclip xtr was inserted and deployed on the mitral valve, reducing mr to a grade of 1.The steerable guide catheter (sgc) returned and revealed damage to the soft tip and braded shaft.

• 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: 22866235
• Report Number: 2135147-2025-04681
• Device Sequence Number: 15787442
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)251021(10)41021R1040
• 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): 10/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2025
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 41021R1040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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
• Patient Sex: Unknown