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	06/24/2021
Type of Reportable Event	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.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 procedure, the 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) could not be advanced within the concomitant microcatheter.The coil was withdrawn from the patient and another 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) was used as a replacement and this coil also became impeded in the microcatheter.The physician attempted to adjust the coil but was not successful; the coil was retracted and it was observed the coil had stretched.Another coil was used to complete the procedure.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30530838) 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 limited information available and without the product and the concomitant microcatheter available for analysis, the reported customer complaint could not be confirmed.Coil stretching is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.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.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.50mm x 2.00cm galaxy g3 mini coil left the manufacturing facility with the coil in a stretched condition or with other anomalies.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.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 procedure, the 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) could not be advanced within the concomitant microcatheter.The coil was withdrawn from the patient and another 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) was used as a replacement and this coil also became impeded in the microcatheter.The physician attempted to adjust the coil but was not successful; the coil was retracted and it was observed the coil had stretched.Another coil was used to complete the procedure.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 08 august 2021.[additional information]: the healthcare professional reported that during a coil embolization procedure, the 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) could not be advanced within the concomitant microcatheter.The coil was withdrawn from the patient and another 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) was used as a replacement and this coil also became impeded in the microcatheter.The physician attempted to adjust the coil but was not successful; the coil was retracted and it was observed the coil had stretched.Another coil was used to complete the procedure.There was no report of any patient adverse event or complication.On 08 august 2021, additional information was received.The information indicated that the target aneurysm was a 3mm x 4mm wide necked aneurysm on the internal carotid artery (ica).The information indicated that the first 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30530838) could not be advanced within the concomitant microcatheter, when the coil was withdrawn, it was found to be unraveled / stretched.Both coils were detached purposely detached.The concomitant microcatheter used was the echelon¿ 10 microcatheter (medtronic).Continuous flush had been maintained through the microcatheter.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.During the coil advancement through the microcatheter, there was resistance at the end of the microcatheter.There was no anomaly observed on the microcatheter.The issue occurred during the coil insertion / advancement through the microcatheter before the coil exited the microcatheter.The coil was purposely detached.It was still difficult to advance the coil through and out of the microcatheter.It was not known if there was any blood flow restriction / reduction as a result of the event.There was no significant delay in the procedure.The procedure was completed with new devices (brand unspecified).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00376.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 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
• MDR Report Key: 12178576
• Report Number: 3008114965-2021-00274
• Device Sequence Number: 909652
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 01/31/2024
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30530838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON¿ 10 MICROCATHETER (MEDTRONIC); GALAXY G3 MINI 1.5MM X 2CM