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

Model Number	SGC0701
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, clip was advanced into ventricle.The grippers were accidently lowered beneath the leaflets.Troubleshooting was performed and was successful.The clip was retracted back into left atrium(la).The gripper was observed to be bent.As a result, a decision was made to remove the clip from the anatomy.While removal, the clip was unable to close completely.The entire system was retracted down to the groin and a small incision was made to allow smooth removal of the system.The mr remained unchanged post procedure.There was no clinically significant delay.On (b)(6) 2025, the hemostasis valve of the steerable guide catheter (sgc) was observed to be torn on returned device analysis.
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
All available information was investigated, and the returned device analysis observed the hemostasis silicone valve to be torn and scratches on the soft tip.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.The investigation determined the torn silicone valve and scratches on the soft tip appear to be due to procedural conditions as the clip delivery system (cds) was removed with the clip not fully closed.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP
• Common Device Name: CATHETER, STEERABLE
• 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 ; 6517565400
• MDR Report Key: 23973205
• Report Number: 2135147-2026-00096
• Device Sequence Number: 18399425
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)261021(10)50421A2014
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190167
• 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,Followup
• Report Date (Section B): 02/11/2026

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: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 50421A2014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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 Age: 84 YR
• Patient Sex: Female