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

Model Number	SGC0801
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a loss of column and air were observed in steerable guide catheter(sgc) after dilator retraction and insertion of wire.Additional aspiration was performed for removal of air.Hypotension was noted.The sgc was removed from the anatomy.A replacement sgc was prepared and advanced inside anatomy.Again, a loss of column and air were observed in sgc after insertion of mitraclip ntw.Additional aspiration was performed for removal of air.The sgc was removed from the anatomy.A sgc replacement was utilized to complete the procedure with deployment of a mitraclip.The mr was reduced to grade 1 post procedure.There was no clinically significant delay reported.
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a loss of column and air were observed in steerable guide catheter(sgc) after dilator retraction and insertion of wire.Additional aspiration was performed for removal of air.Hypotension was noted.The sgc was removed from the anatomy.A replacement sgc was prepared and advanced inside anatomy.Again, a loss of column and air were observed in sgc after insertion of mitraclip ntw.Additional aspiration was performed for removal of air.The sgc was removed from the anatomy.A sgc replacement was utilized to complete the procedure with deployment of a mitraclip.The mr was reduced to grade 1 post procedure.There was no clinically significant delay reported.
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.
Additional Manufacturer Narrative
All available information was investigated and the reported sgc leak/splash (loss of fluid column) and air/gas in device were not confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on information provided and the results of the returned device analysis (unable to confirm the reported issues), the cause for the reported leak/splash (loss of fluid column) and air/gas in the device resulting in hypotension could not be determined.The reported patient effect of hypotension is a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product 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: 50793467
• Report Number: 2135147-2026-06261
• Device Sequence Number: 18522820
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• UDI-Public: (01)05415067050908(17)270714(10)60114R1006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 60114R1006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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: Unknown