MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 MINI 1MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910020
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
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.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30504534 number, and no non-conformances related to the malfunction were identified.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.
Event or Problem Description
As reported by the field, during a coil embolization of a posterior communicating artery aneurysm, a galaxy g3 mini 1mm x 2cm coil (glm910020, 30504534) was used according to the instructions for use (ifu).The coil became stuck inside the headway microcatheter (mc), so the coil was pulled out and found unraveled.The procedure was completed successfully.There was no negative impact on the patient.A continuous flush was done.
Additional Manufacturer Narrative
Product complaint # (b)(4), updated section on this medwatch report: b4, b5, e1, e2, e3, g3, g6, h2 and h10.Section b5: additional information received indicated that there was no evidence of physical material within the device.Section e1.Initial reporter phone: (b)(6), complaint conclusion: as reported by the field, during a coil embolization of a posterior communicating artery aneurysm, a galaxy g3 mini 1mm x 2cm coil (glm910020, 30504534) was used according to the instructions for use (ifu).The coil became stuck inside the headway microcatheter (mc), so the coil was pulled out and found unraveled.The procedure was completed successfully.There was no negative impact on the patient.A continuous flush was done.Additional information received indicated that there was no evidence of physical material within the device.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30504534 number, and no non-conformances related to the malfunction were identified.Impeded in microcatheter with no loss of cerebral target position and coil unraveled are known potential product failures associated with the use of the device.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.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.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 MINI 1MM X 2CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• 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: 17078978
• Report Number: 3008114965-2023-00362
• Device Sequence Number: 17703247
• Product Code: KRD
• UDI-Device Identifier: 10886704080237
• UDI-Public: 10886704080237
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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: 12/31/2023
• Device Model Number: GLM910020
• Device Catalogue Number: GLM910020
• Device Lot Number: 30504534
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY MICROCATHETER
• Patient Sex: Unknown