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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the concerto device was returned for analysis.No microcatheter catheter was returned.The concerto implant coil was returned within an introducer sheath, which was found to be applied correctly, with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was found kinked at the break indicator and the release was pulled.The pushwire was found to be bent within the introducer sheath at ~139.7cm from the proximal end.The implant coil was detached and not returned.The concerto implant coil could not be tested in-house due to its damaged condition.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in cath.Hub¿ and ¿coil r esistance/stuck in catheter¿ could not be confirmed.However, the coil resistance could not be ruled out.The concerto pusher was returned kinked and broken at the break indicator.The implant coil was not returned; therefore, any contribution to resistance could not be assessed.The damage found is consistent with the reported resistance.A possible cause for the damage could have been while the user advances the coil against resistance.This cannot be confirmed.No microcatheter was returned nor were any details provided, other than the devices was a non-medtronic device; therefore, compatibility was unable to be determined.Other possible cause for the resistance are but not limited to damage to the coil due to excessive tightening of rhv, sheath not properly seated in hub, and catheter hub transition.The likely cause for resistance cannot be determined.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 during a procedure involving the concerto coil did not pass through the microcatheter.The product was being used as per the instructions for use.A new medtronic device was used to complete the procedure.No patient complications have been reported as a result of this event.Additional information received reported the resistance was in the catheter hub.Continuous saline flush was administered and maintained as indicated in the instructions for use (ifu).There was no kink/damage to the coil or catheter observed after removal.The catheter was not a medtronic product.

• 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: 22516188
• Report Number: 9617601-2025-00633
• Device Sequence Number: 12901644
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: (01)00847536044975(17)260328(10)226235089
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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 Expiration Date: 03/28/2026
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 226235089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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