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

Model Number	SGC0701
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented for a mitraclip procedure.During the preparation, a steerable guide catheter (sgc) would not hold the column as dilator entered into back of guide and it was replaced with new sgc.All steps were performed as per ifu.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
All available information was investigated, and the reported leak (loss of fluid column) was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented for a mitraclip procedure.During the preparation, a steerable guide catheter (sgc) would not hold the column as dilator entered into back of guide and it was replaced with new sgc.All steps were performed as per ifu.There were no adverse patient effects or clinically significant delays reported.

• Brand Name: MITRACLIP
• Common Device Name: CATHETER, STEERABLE
• 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 ; 6517565400
• MDR Report Key: 23821307
• Report Number: 2135147-2025-07432
• Device Sequence Number: 21333748
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)260909(10)50311R2112
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/22/2025

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 Expiration Date: 09/09/2026
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 50311R2112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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 Sex: Male