MAUDE Adverse Event Report: MEDTRONIC MEXICO 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	03/07/2024
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) but the coil did not pass through the microcatheter that was used in the procedure.A new medtronic device was used to complete the procedure.The reported device and any accessory devices prepared as indicated in the ifu.No patient symptoms or complications were associated with this event.Additional information received reported the catheter was not a medtronic device.No other information was known or available.
Additional Manufacturer Narrative
Product analysis #805104343:equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5 as found condition: the concerto device was returned for analysis within shipping box; within sealed plastic biohazard pouch; within an opened concerto inner pouch; within dispenser coil and outside its returned 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.Dried blood was found within the introducer sheath.The concerto pusher was found broken between the positive load indicator and the break indicator with the two segments retained by the release wire.The pusher was found kinked at the break indicator.The coin was found retracted out of the lumen stop.The concerto implant coil was already detached and not returned for analysis.Testing/analysis: the concerto coil could not be used for resistance testing as the implant was already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed but could not be ruled out.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain sufficient continuous flush, damaged micro catheter, incompatible micro catheter, or tortuous anatomy.Customer only reported device was used per ifu.Therefore, the likely cause could not be determined.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The pusher was found kinked, potentially due to advancing against the reported resistance.The pusher was found broken, detaching the implant as expected by the detachment subassemblies.The cause of the break could not be determined.It is possible the blood found within the introducer sheath contributed towards the reported resistance.It is likely insufficient continuous flush was used, causing blood to backflow up the micro catheter and into the introducer sheath.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: 19519989
• Report Number: 9612164-2024-02792
• Device Sequence Number: 15538027
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: 00847536044975
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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 Expiration Date: 07/13/2026
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 226959378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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