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

Model Number	NV-6-20-HELIX
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of nv-6-20-helix, lotno:226101609 found the concerto pusher broken at the break indicator with the release wire also broken.The proximal segment was not returned for analysis.The concerto pusher was found kinked/bent throughout the entire length of the pusher.The coin was found fully retracted out of the lumen stop.The shield coil was found undamaged, and the implant coil was found already detached and not returned for analysis.The concerto coil could not be used for resistance testing due to the damaged condition and as the implant was already detached.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed.The pusher was found severely kinked throughout the entire length.Kinking typically is indicative of resistance, however, as the kinking was found throughout the entire length of the device and due to the severity of the kinking, it is possible the kinking occurred during handling and shipping back to medtronic.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, or tortuous anatomy.The pusher was found broken at the break indicator and the release wire was retracted, detaching the implant coil as expected by the detachment subassemblies.The customer did not report any detachment attempts.As the unknown terumo 2.7f micro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 was not reported, compatibility could not be assessed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil was getting stuck to the microcatheter terumo 2.7fr.The coil was damaged.No patient symptoms or further complications were reported as a result of this event.  ancillary devices include a terumo 2.7fr microcatheter.

• 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: 18424741
• Report Number: 9612164-2024-00007
• Device Sequence Number: 7771470
• Product Code: KRD
• UDI-Device Identifier: 00847536044951
• UDI-Public: 00847536044951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/02/2024

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: 03/02/2026
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: 226101609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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