MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910010
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that during a coil embolization for a 3mm anterior communicating artery (acom) subarachnoid hemorrhage (sah), the complaint coil, a 1.00mm x 1.00cm galaxy g3 mini coil (glm910010 / 30504533) was used as the fourth coil; it was implanted.However, the coil was unable to be detached even though the detachment button of the enpower cable was pressed several times.The complaint coil was removed from the patient and it was reported that the procedure was completed with a total of five (5) coils.The complaint documented that the physician has familiarity with using the complaint coil.It was prepped without any issues.Continuous flush was maintained through the concomitant headway microcatheter (microvention).There was no report of any patient adverse event or complication.It was reported that the complaint product is not available to be returned.On 07-feb-2022, additional information was received.The information indicated that the coil was successfully removed from the patient; no stretched condition was reported.The coil was still attached to the delivery system when it was removed from the patient.Upon pressing the power button, all the lights illuminated; the green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beep was heard.The complaint coil was removed from the patient and replaced (further information regarding the replacement coil is not known); the procedure was safely competed.The reported event did not result in any clinically significant delay in the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30504533) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot be confirmed.Based on the review of the manufacturing documentation, 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.
Event or Problem Description
The healthcare professional reported that during a coil embolization for a 3mm anterior communicating artery (acom) subarachnoid hemorrhage (sah), the complaint coil, a 1.00mm x 1.00cm galaxy g3 mini coil (glm910010 / 30504533) was used as the fourth coil; it was implanted.However, the coil was unable to be detached even though the detachment button of the enpower cable was pressed several times.The complaint coil was removed from the patient and it was reported that the procedure was completed with a total of five (5) coils.The complaint documented that the physician has familiarity with using the complaint coil.It was prepped without any issues.Continuous flush was maintained through the concomitant headway microcatheter (microvention).There was no report of any patient adverse event or complication.It was reported that the complaint product is not available to be returned.On 07-feb-2022, additional information was received.The information indicated that the coil was successfully removed from the patient; no stretched condition was reported.The coil was still attached to the delivery system when it was removed from the patient.Upon pressing the power button, all the lights illuminated; the green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beep was heard.The complaint coil was removed from the patient and replaced (further information regarding the replacement coil is not known); the procedure was safely competed.The reported event did not result in any clinically significant delay in the procedure.

• Brand Name: GALAXY G3 MINI 1MM X 1CM
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13498838
• Report Number: 3008114965-2022-00056
• Device Sequence Number: 4296078
• Product Code: KRD
• UDI-Device Identifier: 10886704080213
• UDI-Public: 10886704080213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/09/2022

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: 12/31/2023
• Device Model Number: GLM910010
• Device Catalogue Number: GLM910010
• Device Lot Number: 30504533
• 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: 01/23/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER CONTROL CABLE; HEADWAY MICROCATHETER (MICROVENTION)
• Patient Sex: Unknown