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

Model Number	GLM910010
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular coil embolization to treat a subarachnoid hemorrhage (sah), there was difficulty winding the coils including the competitor target (stryker) coils.It was reported that the coils were unable to fit the target aneurysm.The complaint coil, a 1.00mm x 1.00cm galaxy g3 mini (glm910010 / 30485176) was removed from the patient¿s body and an attempt to resheath was made, but the sheath was reported as damaged and the resheathing was not possible.The concomitant microcatheter used was an excelsior® sl-10® microcatheter (stryker).It was not known if a continuous flush was maintained through the microcatheter during the procedure.There was no negative impact on the patient.On 10-mar-2023, additional information was received.The information indicated that the complaint coil failed to conform to the aneurysm.There was no resistance during the advancement of the complaint coil through the concomitant microcatheter.The coil was not positioned at a relatively sharp angle to the microcatheter.The information indicated that it was not necessary to remove the concomitant microcatheter when the complaint coil was removed from the patient¿s anatomy.Based on the additional information received on 10-mar-2023, the event has been deemed usfda reportable under title 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.Initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30485176) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot 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 may have contributed to the reported failure.A manufacturing documentation review was performed.There is no indication that the event is related to the device manufacturing process.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 803.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: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16526944
• Report Number: 3008114965-2023-00162
• Device Sequence Number: 20157986
• 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): 03/10/2023

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: 11/30/2023
• Device Model Number: GLM910010
• Device Catalogue Number: GLM910010
• Device Lot Number: 30485176
• 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: 03/10/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR® SL-10® MICROCATHETER (STRYKER)
• Patient Sex: Unknown