MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915020
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30532739) was the third (3rd) coil in the procedure.The coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the concomitant microcatheter (unspecified brand) at the same time.After inspection, the coil was observed in stretched condition.It was reported that the physician used ¿a same like product¿ and the procedure was successfully completed.There was no report of any patient adverse event or complication.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30532739) 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.With the information available and without the product and the concomitant microcatheter available for analyses, the reported customer complaint cannot be confirmed.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.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.Based on the manufacturing documentation review, 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.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 the 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30532739) was the third (3rd) coil in the procedure.The coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the concomitant microcatheter (unspecified brand) at the same time.After inspection, the coil was observed in stretched condition.It was reported that the physician used ¿a same like product¿ and the procedure was successfully completed.There was no report of any patient adverse event or complication.

• Brand Name: GALAXY G3 MINI 1.5MM X 2CM
• 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: 12841125
• Report Number: 3008114965-2021-00554
• Device Sequence Number: 11835303
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30532739
• 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: 11/02/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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