MAUDE Adverse Event Report: Medtronic Ireland CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the implant of a transcatheter aortic valve (tav), during the loading phase, a bent strut was visually observed after "marrying" the tip guide tube and the outflow cone, constituting a misload.Subsequently, the valve was removed and the same delivery catheter system (dcs) and compression loading system (cls) were used to load a new valve.Following the successful loading of the second valve, a confida guidewire was inserted into the patient, and complete heart block (chb) was observed.Temporary pacing was then initiated for the rest of the procedure.A pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic (beckton dickson true) 22 millimeter (mm) balloon, and the dcs was inserted into the patient via the right carotid artery.Following successful deployment of the valve, the temporary pacing was turn off, however the chb remained.Subsequently, a permanent pacemaker was implanted.A procedural delay of 3 hours occurred as a result.Additional information was received to report the valve load was performed by an experienced valve loader.The misload was identified via visual inspection and was "seen early enough that we did not fluoro it".Additional information was received to confirm the chb did not resolve during the implant procedure.Per the sales representative, the tav implant team was unable to run off of the temporary pacer.
Additional Manufacturer Narrative
D10.Continuation - concomitant medical devices in use during the event include: medtronic brand name: evolut fx plus valve; product id: evfxplus-29; serial # (b)(6); implant date: (b)(6) 2026 medtronic brand name: evolut fx dcs; product id: d-evolutfx-2329, lot #: 0013393794, not implantable medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer (Section G): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50012469
• Report Number: 9612164-2026-03727
• Device Sequence Number: 9534823
• Product Code: DQX
• UDI-Device Identifier: 00763000758646
• UDI-Public: (01)00763000758646(17)290131(10)92503726(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132623
• 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): 07/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92503726
• 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: 06/08/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 01/31/2026
• 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: "See H11...."
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 157 LB