MAUDE Adverse Event Report: MEDTRONIC IRELAND CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Select patient information cannot be included in the regulatory report due to regional privacy regulations.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.
Event or Problem Description
It was reported that the tip of the guidewire gwbc30 confida 26l was found to be frayed when removed from its original packaging, and an alleged product issue was identified.The wire was not used, and there was no effect on the patient.The healthcare professional selected a new wire and continued the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, visual analysis showed the guidewire was received in two sealed pouches.The stainless-steel wire had separated from the coil.Coil separation at the j-tip.The glued distal tip appeared intact.The tapered glue bond at the coil /core wire transition was intact.The transition area on the left was separating.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 CA ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23323695
• Report Number: 2025587-2025-05808
• Device Sequence Number: 18795765
• Product Code: DQX
• UDI-Device Identifier: 00763000758646
• UDI-Public: (01)00763000758646(17)280831(10)92402847(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92402847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2025
• 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: Unknown