MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 MINI 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM920060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization procedure of a pediatric case, a galaxy g3 mini 2mm x 6cmmini coil (glm920060, 30558369) was prepped per the instructions for use (ifu) and used as the first coil.When the galaxy was inserted into the unspecified microcatheter (mc), there was a resistance, and the coil was pulled.Replaced to another coil, a galaxy g3 mini 2mm x 6cm (glm920060, 30558133), but the size did not fit the lesion, therefore the second coil was re-sheathed and the sheath got damaged at that time.The procedure was completed successfully with coils with different lot.There was no negative impact to the patient.A continuous flush was done.Additional information received indicated that it was not necessary to remove or replace the microcatheter.Nothing was noted to be obstructing the microcatheter.Based on the product analysis of the devices received, the embolic coil of the first device is kinked and the embolic coil of the second device is stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found kinked, meeting us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).A non-sterile galaxy g3 mini 2mmx6mm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the coil was partially inside the introducer.No appearance of damage was observed.The device was inspected under microscopic magnification, and it was found that the introducer was opened by a kinked condition at the point where the core wire protrudes.The core wire was found with a kinked condition.The embolic coil was found kinked, and it remains attached to the resistance heating (rh).No other damages were found in the device.The issue documented that the introducer got damaged was confirmed based on the kinked condition found on it.With the limited information available, the root cause of such damages cannot be conclusively determined.According to the risk documentation, device damage is a potential failure mode that can occur during the microcoil placement due to an introducer tip and microcatheter hub being misaligned and where force is inadvertently applied, resulting in the kinked condition observed in the introducer.There could be other factors that may have contributed to the issue encountered during the procedure.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.The damage observed in the coil was not originally documented in the complaint; however, it could be the result of the difficulty experienced during the procedure that could not be replicated in the laboratory.There is no indication that the issue reported is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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.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.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 3008114965-2023-00558.

• Brand Name: GALAXY G3 MINI 2MM X 6CM
• 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; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17459819
• Report Number: 3008114965-2023-00559
• Device Sequence Number: 15269737
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: 10886704080312
• 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
• Report Date (Section B): 08/04/2023

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: 04/30/2024
• Device Catalogue Number: GLM920060
• Device Lot Number: 30558369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GALAXY G3 MINI 2MM X 6CM; UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown