MAUDE Adverse Event Report: Abbott Medical MitraClip¿ G5 Steerable Guide Catheter; Catheter, Percutaneous

Model Number	SGC0801
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available information was investigated, and the reported split sgc soft tip was confirmed as a deformed soft tip via device analysis.The reported failure to advance could not be replicated in a testing environment.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 did not indicate a lot-specific quality issue.Based on available information, the cause of the reported failure to advance sgc was unable to be determined.The reported kinked sgc tip was likely a result of procedural circumstances.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) 2026, a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a steerable guide catheter (sgc) was attempted to be advanced within the patient whne excessive resistance was identified.Troubleshooting was performed and the device was removed from the patient.The device was examined and it was visualized that there was a split in the tip of the guide.A replacement sgc was selected and advanced within the patient.The procedure was performed successfully and an mitraclip was implanted.The procedure was discontinued, the final mr was reduced to grade 1.There were no adverse patient effects or clinically significant reported.

• Brand Name: MitraClip¿ G5 Steerable Guide Catheter
• Common Device Name: Catheter, Percutaneous
• 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: 50407508
• Report Number: 2135147-2026-05774
• Device Sequence Number: 10489531
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• UDI-Public: (01)05415067050908(17)270930(10)60402R1090
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K243224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGC0801
• Device Catalogue Number: SGC0801
• Device Lot Number: 60402R1090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2026
• 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
• Patient Sex: Unknown