MAUDE Adverse Event Report: MEDTRONIC MEXICO CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the concerto coil detacher failed to function during procedure.Completed the procedure using a new product.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product analysis #(b)(4) :equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the concerto pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened concerto outer carton; within an opened concerto inner pouch and within an introducer sheath.The unknown micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The concerto pusher was found broken at the break indicator (figure c).The proximal segment (actuator interface, positive load indicator, and portion of the coupler tube) was not returned for analysis.The release wire and coin were fully retracted out of the lumen stop/pusher and not returned for analysis.The shield coil was found undamaged.The implant coil was already detached and not returned for analysis.The lumen stop was found damaged (figure e).Testing/analysis: the inner diameter of the lumen stop could not be reliably measured due to the damage.Conclusion: based on the analysis performed, the customer report of ¿non-detachment" could not be confirmed as the implant was already detached and not returned for analysis.However, it could not be ruled out.The lumen stop was found damaged, which could indicate that the coin was stuck within the lumen stop.As the proximal pusher, release wire/coin, implant coil and instant detacher were not returned for analysis, any contribution of these subassemblies and the instant detacher towards the non-detachment could not 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.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19202959
• Report Number: 9612164-2024-02037
• Device Sequence Number: 8106818
• Product Code: KRD
• UDI-Device Identifier: 00847536044869
• UDI-Public: 00847536044869
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 08/10/2026
• Device Model Number: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: 227135802
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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