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

Model Number	NV-3-4-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	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of nv-3-4-helix, lot no:228342425 as found condition (condition of returned device): the concerto implant coil was returned for analysis within a shipping box; within an opened concerto implant coil outer carton; within an opened concerto implant coil inner pouch and within a dispenser track.The concerto implant coil was returned within introducer sheath.Visual inspection/damage location details: the concerto implant coil was not secured in the rubber stopper and guidewire clip.The concerto implant pushwire assembly was not returned.The implant coil was found to be detached, stretched and damaged within introducer sheath.The implant coil was unable to be pushed out further from introducer sheath for additional analysis as it was found to be stuck.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was confirmed; however, the pushwire assembly was not returned.It is possible the reported damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was unable to be confirmed as the pushwire assembly was not returned.Pushwire damage can occur if the user advances the device against resistance.However, there was not any friction or difficulty during testing or delivery.Therefore, the cause for the pushwire kink could not be confirmed.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
Medtronic received a report that the tech opened the package and said that the detachment end was bent in the pushwire proximal segment.There was no friction or difficulty during testing or delivery.The continuous flush was not administered during the procedure.The reported device and any accessory devices were prepared as indicated in the ifu.Additional information received reported additional information received report there was no damage or evidence of tampering to device packaging.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19963641
• Report Number: 9612164-2024-03674
• Device Sequence Number: 7136945
• Product Code: KRD
• UDI-Device Identifier: 00847536044890
• UDI-Public: 00847536044890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/12/2024

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 Model Number: NV-3-4-HELIX
• Device Catalogue Number: NV-3-4-HELIX
• Device Lot Number: 228342425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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