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

Model Number	SGC0801
Medical Device Problem Codes	Difficult to Remove (1528); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ on a patient with prolapsed posterior leaflet and rotated heart.A steerable guide catheter (sgc) (60317a2077) and a mitraclip xtw clip delivery system (cds) (60429a1098) were prepared for use and inserted.However, upon initial m down steering, the sgc tip and cds moved in the wrong direction upon turning the knob.In the physician¿s opinion, the sgc and the cds were miskeyed due to fluoroscopy deflection.Therefore, a decision was made to retract the cds into the sgc.However, while retracting the cds into the sgc, the clip frictional elements engaged with the soft tip of the sgc and became stuck.Troubleshooting was performed to remove the cds from the sgc but was not successful.Therefore, a decision was made to remove the cds and the sgc together as one system.Once the cds and the sgc were safely in the inferior vena cava (ivc), the clip was able to be dislodged from the tip of the sgc.The entire system was then removed from the patient.A new sgc and a new clip were prepared for the procedure.Two clips were then implanted, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported unintended movement (guide steering issues) and difficult to remove cds from sgc could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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 Medical Northpoint Reg 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50484088
• Report Number: 2135147-2026-05870
• Device Sequence Number: 10135926
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• UDI-Public: (01)05415067050908(17)270922(10)60317A2077
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 60317A2077
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Steerable guide catheter
• Patient Sex: Unknown