MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-3-8-HELIX
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition: the concerto device was returned within a shipping box, within a sealed plastic biohazard pouch, within a tied-up pouch, within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the proximal pusher was found not within the black guidewire clip (figure c).The proximal concerto pusher was found kinked and broken.The concerto implant coil was found already detached (figure d).The implant coil was found undamaged.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damaged/deformed out of pkg¿ could not be ruled out.The pusher was found kinked/broken.It is possible the damages occurred during production, during transportation, or upon opening the package and attempting to remove the product or after removing it from the package.There is an indication that the event is related to a manufacturing issue, therefore, a dhr review will be performed.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 coil concerto helix 3mm x 8cm device was found to be kinked while opening.There was no patient involved.Additional information was received.There was no damage or evidence of tampering to the device packaging.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.

• 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 ; 7635265677
• MDR Report Key: 23031377
• Report Number: 9617601-2025-01406
• Device Sequence Number: 18520191
• Product Code: KRD
• UDI-Device Identifier: 00847536044906
• UDI-Public: (01)00847536044906(17)280207(10)230651046
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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 Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: 230651046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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