MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 9MM X 33CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR180933
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an interventional embolization procedure of an aneurysm, during the attempt to position a 9mm x 33cm micrusframe 18 coil (mfr180933 / 30404330), ¿the detachment of the pusher occurred while the coil was still partially positioned and without any hydro electrolytic command for the operator.¿ the coil was inserted into the aneurysm.There was no report of any patient consequence.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that during an interventional embolization procedure of an aneurysm, during the attempt to position a 9mm x 33cm micrusframe 18 coil (mfr180933 / 30404330), ¿the detachment of the pusher occurred while the coil was still partially positioned and without any hydro electrolytic command for the operator.¿ the coil was inserted into the aneurysm.There was no report of any patient consequence.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30404330) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: MICRUSFRAME18 9MM X 33CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14721691
• Report Number: 3008114965-2022-00392
• Device Sequence Number: 4878168
• Product Code: KRD
• UDI-Device Identifier: 10886704078234
• UDI-Public: 10886704078234
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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: 06/30/2023
• Device Model Number: MFR180933
• Device Catalogue Number: MFR180933
• Device Lot Number: 30404330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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 Age: 61 YR
• Patient Sex: Unknown