MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 5MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120515
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg, section e1.Initial reporter phone: (b)(6).This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00943 and 3008114965-2023-00944.
Event or Problem Description
As reported by the field, after a lighthouse microcatheter (mc) was placed as per the instructions for use (ifu), coil embolization was initiated.A galaxy g3 8mm x 24cm coil (gly120824, 30530863) was inserted and got stuck inside the microcatheter (mc).The coil could not be advanced, so it was retrieved.Then, replaced with another new coil with the same size, which was implanted with no issues.After that, a few additional coils were implanted.A galaxy g3 5mm x 15cm coil (gly120515, 30860250) was used and wound.Attempted to detached, but the lamp did not illuminate and could not be detached when energized.Replaced with a second galaxy g3 5mm x 15cm coil (gly120515, lot unknown) but the lamp came on and off and was not stable.Since it was unclear whether the coil could be detached, the coil was retrieved and replaced with another coil of a different size and implanted.The procedure was successfully completed.There was no negative impact to the patient.It is unknown if a continuous flush was done.Additional information received on 08-dec-2023 indicated that the replaced coils were used successfully with the microcatheter prior to or after the encountered resistance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, after a lighthouse microcatheter (mc) was placed as per the instructions for use (ifu), coil embolization was initiated.A galaxy g3 8mm x 24cm coil (gly120824, 30530863) was inserted and got stuck inside the microcatheter (mc).The coil could not be advanced, so it was retrieved.Then, replaced with another new coil with the same size, which was implanted with no issues.After that, a few additional coils were implanted.A galaxy g3 5mm x 15cm coil (gly120515, lot unknown) was used and wound.Attempted to detached, but the lamp did not illuminate and could not be detached when energized.Replaced with a second galaxy g3 5mm x 15cm coil (gly120515, lot unknown) but the lamp came on and off and was not stable.Since it was unclear whether the coil could be detached, the coil was retrieved and replaced with another coil of a different size and implanted.The procedure was successfully completed.There was no negative impact to the patient.It is unknown if a continuous flush was done.Additional information received on 08-dec-2023 indicated that the replaced coils were used successfully with the microcatheter prior to or after the encountered resistance.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 5MM X 15CM
• 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 ; 3035526892
• MDR Report Key: 18319571
• Report Number: 3008114965-2023-00943
• Device Sequence Number: 7081367
• Product Code: KRD
• UDI-Device Identifier: 10886704077510
• UDI-Public: 10886704077510
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 06/30/2025
• Device Catalogue Number: GLY120515
• Device Lot Number: 30860250
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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: GALAXY G3 8MM X 24CM; LIGHTHOUSE MICROCATHETER
• Patient Sex: Unknown