MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 5MM X 9.7CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100509
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, prior to use, a micrusframe10 5mm x 9.7cm coil (mfr100509, 30537018) came out of the packaging frayed.There was no patient injury as the device was not clinically used.The procedure was successfully completed.No additional information is available.
Additional Manufacturer Narrative
Product complaint (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > (b)(6) updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.Complaint conclusion: as reported by the field, prior to use, a micrusframe10 5mm x 9.7cm coil (mfr100509, 30537018) came out of the packaging frayed.There was no patient injury as the device was not clinically used.The procedure was successfully completed.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30537018 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined.The instructions for use (ifu) indicate that upon receipt of the device, inspect the shipping carton and the unit for signs of damage.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MICRUSFRAME10 5MM X 9.7CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16903627
• Report Number: 3008114965-2023-00282
• Device Sequence Number: 5561528
• Product Code: KRD
• UDI-Device Identifier: 10886704077848
• UDI-Public: 10886704077848
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 02/29/2024
• Device Model Number: MFR100509
• Device Catalogue Number: MFR100509
• Device Lot Number: 30537018
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2021
• 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