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

Model Number	SGC0801
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 on a patient with a prolapsed posterior leaflet, thick leaflet, and pre-existing flail.A steerable guide catheter (sgc) and a mitraclip ntw were prepared per the instructions for use (ifu).A transseptal sheath was inserted, but difficulties advancing the transseptal sheath occurred.After transeptal access the groin was dilated with a 16f dilator with no difficulty.After obtaining transseptal access, the steerable guide catheter (sgc) was inserted.However, difficulty advancing the sgc occurred.Therefore, the sgc was removed, and the groin was dilated with a 22f dilator.The sgc was inserted again, but during advancement, resistance was encountered.The sgc was able to cross and was successfully advanced into position for the procedure.A mitraclip ntw was then inserted, and drips were slowed once the clip exited the guide.However, imaging revealed ¿bubbles¿ on the left side of the heart.After confirming drips where not fully opened on the device and anesthesia was not giving any fluids, it was discovered that there was air in the hemostatic valve of the guide.The patient became bradycardic and required atropine.Aspiration was then immediately performed until blood filled the hemostatic valve chamber.The stopcock was turned off to the guide and they stopped aspiration.However, it was observed that the hemostatic valve chamber did not hold column.Aspiration was resumed.The clip was then removed from the sgc, and the sgc was removed and replaced.However, during the exchange, bleeding from the access site was noted.The patient¿s heart rate had returned to normal.While re-prepping the clip in was noted that the clip introducer did not seem to be holding fluid.Three different stopcocks were used with the same issue, and it was suspected this may have been the cause of the air.A new ntw was then prepared per the instructions for use (ifu), inserted, and successfully deployed on the mitral valve, reducing mr to trace.It was noted that the patient remained stable.However, upon removal of the clip delivery system (cds) and the sgc, despite using a perclose, the patient continued to bleed from the access site.Pressure was applied at the access site, and a vascular surgeon was consulted.It was noted that the vascular surgeon suspected that the bleed was arterial and decided to open the groin for inspection and repair.It was confirmed that a femoral artery perforation occurred and performed repair of the perforation.The patient was reported to be stable and discharged from the hospital.No additional information was provided.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

• 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: 50820727
• Report Number: 2135147-2026-06337
• Device Sequence Number: 18810873
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• UDI-Public: (01)05415067050908(17)270723(10)60114A2003
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGC0801
• Device Catalogue Number: SGC0801
• Device Lot Number: 60114A2003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: White