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

Catalog 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	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event was reported via a key monitoring; during an endovascular embolization procedure in the 63-year-old female patient, the 1.50mm x 2.00cm galaxy g3 mini (glm915020 / 30895986) was impeded in the concomitant microcatheter (competitor brand) and could not be further advanced.The physician tried to retract the coil and it was found that the coil had unraveled / stretched.The physician removed the coil and the microcatheter from the patient and replaced the coil to complete the procedure using the same original microcatheter.There was no report of any negative patient impact.A photo of the complaint device and a procedure image were included in the complaint.The photo of the device will be reviewed by the product analysis team and the procedure image will undergo independent physician review.On 12-aug-2024, additional information was received.The information indicated that target aneurysm is on the internal carotid artery (ica) bed segment.The aneurysm is approximately 3mm, regular shaped aneurysm.Per the information, a continuous flush was maintained through the microcatheter.The complaint coil had not been withdrawn and repositioned.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.Prior to the complaint coil, three coils went through the same microcatheter without resistance.The three centering coils were delivered smoothly.The reported issue occurred during the advancement of the complaint coil into the target aneurysm.The microcatheter was not repositioned over the coil.There was no additional damage to the complaint coil aside from the reported stretched / unraveled condition when it was removed.There was no blood flow restriction / reduction as a result of the reported issue.The complaint coil was not replaced; the additional information indicated no replacement, ¿end of embolization step.¿ there was no delay in the procedure as a result of the reported issue.There was no patient adverse event, no negative patient impact.The patient was discharged.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.The procedure image is pending independent physician review.The photo of the complaint product was reviewed by the product analysis team.The review is documented below.[photo review]: the photo included in the complaint file showed a severely stretched coil.The coil is shown still attached to the resistance heating (rh) coil.The blue fiber can be seen exposed due to the stretched condition of the coil.No other damages can be observed; the rest of the device is not shown in the photo.The reported issue documented in the complaint is confirmed based on the photo.This investigation was performed based only on the images provided.According to the received information, the device was discarded.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30895986) 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 product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.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 device; however, it is possible that clinical and procedural factors, including 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.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 27-aug-2024.[additional information]: on 27-aug-2024, additional information was received.The information indicated that the cerenovus sales representative had updated the event description to state that, ¿the surgeon did not replace other coil and directly ended the aneurysm filling.The procedure was completed after the subsequent surgical steps were completed normally.¿ 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 independent review of the medical image included in the complaint.The review was completed on 15-oct-2024.The assessment is documented below.The image is a subtracted image of a distal access catheter with a microcatheter marker and a radiopaque marker that is most likely of a partially unraveled coil.The root cause of the event cannot be discerned from the description and image.Physician name and date reviewed: (b)(6) md, msc, (b)(6) 2024.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
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 20007692
• Report Number: 3008114965-2024-00771
• Device Sequence Number: 4431473
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: (01)10886704080138(11)220818(17)250731(10)30895986
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2024

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: 07/31/2025
• Device Catalogue Number: GLM915020
• Device Lot Number: 30895986
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 10/15/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2022
• 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: MICROCATHETER (UNSPECIFIED BRAND).
• Patient Age: 63 YR
• Patient Sex: Female