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

Model Number	NV-2-6-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the product was being used as per the instructions for use (ifu), however, the concerto helix coil got stuck within the microcatheter.A new medtronic device was used to complete the procedure.Additional information was received stating that a continuous catheter flush was administered during the procedure.The catheter was not a medtronic product.The cause of the resistance was not determined.The information is confirmed by the physician.No patient symptoms or complications were associated with this event.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, an opened concerto outer carton, an opened concerto inner pouch, within a small plastic biohazard bag and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The pushwire was found to be broken at ~7.3cm (with release wire pulled), bent at ~21.9cm, and bent at ~54.9cm from the proximal end; addition the pushwire was found to be bent within the introducer sheath at ~40.5cm ,a bent at ~9.7cm from the distal end.The concerto implant coil was found to be detached from the pushwire.The implant coil was found to be damaged within the introducer sheath.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the damaged found with the concerto device was consistent with ¿advancing against resistance¿.A possible cause of ¿coil resistance/stuck in catheter¿ may have been caused by ¿damage or kink to pushwire¿.The concerto device was returned bent, broken and detached from the pushwire.Therefore, it is possible the damage may have been caused while the user advance the concerto device against resistance within the microcatheter, which resulted in pushwire damaged (bends/breaks) and cause the implant coil to detach from the pushwire within the introducer sheath, finally resulting in the concerto device getting stuck within the non-medtronic microcatheter.A few other possible cause of ¿coil resistance/stuck in catheter¿ are but not limited to patients vessel tortuosity and incompatible catheter; however, the root cause was unable to be determined.No microcatheter was returned for assessment; therefore, compatibility could not be verified.Any contribution the microcatheter had towards the resistance was unable to be confirmed.The devices were reported to be prepared per the ifu; in addition, a continuous catheter flush was administered durin g the procedure.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: 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: 23560672
• Report Number: 9617601-2025-02762
• Device Sequence Number: 10108183
• Product Code: KRD
• UDI-Device Identifier: 00847536044876
• UDI-Public: (01)00847536044876(17)270924(10)229737221
• 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): 11/14/2025

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-2-6-HELIX
• Device Catalogue Number: NV-2-6-HELIX
• Device Lot Number: 229737221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown