MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-7-30-HELIX
Medical Device Problem Codes	Break (1069); Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; +1(763)526-5677
• MDR Report Key: 50410847
• Report Number: 9617601-2026-05257
• Device Sequence Number: 9201292
• Product Code: KRD
• UDI-Device Identifier: 00847536044968
• UDI-Public: (01)00847536044968(17)270424(10)228751790
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• 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,Followup
• Report Date (Section B): 09/22/2026

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: NV-7-30-HELIX
• Device Catalogue Number: NV-7-30-HELIX
• Device Lot Number: 228751790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/25/2026; 08/25/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/22/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 321 LB