MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915040
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the internal carotid-posterior communicating artery (icpc), the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14811) got impeded inside the concomitant phenom¿ 21 microcatheter (medtronic).It was reported that there was continuous flush through the microcatheter.The complaint coil was removed with the microcatheter and replaced with another coil.The procedure was completed.There was no report of any patient injury or complication associated with the reported device issue.The complaint coil is not available to be returned for evaluation and analysis.
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 during a coil embolization procedure with the target aneurysm located at the internal carotid-posterior communicating artery (icpc), the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14811) got impeded inside the concomitant phenom¿ 21 microcatheter (medtronic).It was reported that there was continuous flush through the microcatheter.The complaint coil was removed with the microcatheter and replaced with another coil.The procedure was completed.There was no report of any patient injury or complication associated with the reported device issue.The complaint coil is not available to be returned for evaluation and analysis.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l14811) 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 concomitant microcatheter available for analysis, the reported customer complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 24-oct-2021.[additional information]: the healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the internal carotid-posterior communicating artery (icpc), the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14811) got impeded inside the concomitant phenom¿ 21 microcatheter (medtronic).It was reported that there was continuous flush through the microcatheter.The complaint coil was removed with the microcatheter and replaced with another coil.The procedure was completed.There was no report of any patient injury or complication associated with the reported device issue.The complaint coil is not available to be returned for evaluation and analysis.On 09-nov-2021, additional information was received.The information indicated that nothing was noted to be obstructing the phenon 21 microcatheter; the same microcatheter was used to delivery the replacement coil to complete the procedure.E.1: the initial reporter phone: (b)(6).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 1.5MM X 4CM
• 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: 12771520
• Report Number: 3008114965-2021-00536
• Device Sequence Number: 11549509
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• 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,Followup
• Report Date (Section B): 11/10/2021

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: 01/31/2022
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: L14811
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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: PHENOM¿ 21 MICROCATHETER (MEDTRONIC)
• Patient Sex: Unknown