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

Model Number	SGC0801
Medical Device Problem Codes	Leak/Splash (1354); Unstable (1667); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (mr) and prolapsed posterior leaflet for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.Post deployment, the clip delivery system was retracted from the steerable guide catheter(sgc).The stopcock attached to port on the hemostasis valve on the guide came unscrewed from the port.The port was sealed with finger to prevent loss of column and resealed the port using new three way stopcock.Aspiration was performed for removal of air.The procedure was continued with deployment of another mitraclip.The mr was reduced to grade 1 post procedure.There was no clinically significant delay reported.
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, a definitive cause for the reported stopcock becoming unscrewed from the hemostatic valve port resulting in air and leak cannot be determined.The reported unexpected medical intervention was a result of case-specific circumstances.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 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: 50844374
• Report Number: 2135147-2026-06371
• Device Sequence Number: 21321516
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• 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): 09/21/2026

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: 60427R1028
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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: MitraClip
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown