MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 4MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120412
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
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 stretched.The findings meet us regulatory reporting criteria.Section e1.Initial reporter phone: (b)(6).A non-sterile galaxy g3 4mm x 12mm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The coil component was inspected under microscopic magnification, and it was found to be severely stretched, and as a result of the severity of the stretch, the blue fiber was exposed.The coil is still in one piece, and it remains attached to the resistance heating (rh) coil, and this was found not softened indicating that the detachment process was not initiated.The issue documented regarding the resistance between the complaint coil and the involved microcatheter could not be evaluated through functional testing due to the returned condition of the coil prevent the inability to move the coil through the introducer.Coil stretching 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.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement from the inability to position the microcoil, which can result in coil stretching.The coil stretching 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, and based on this the customer complaint was able to be confirmed.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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as coil stretching from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, 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: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.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 three products involved with the complaint and the associated manufacturer report numbers are , 3008114965-2023-00435 and 3008114965-2023-00436.
Event or Problem Description
It was reported that after placing an unspecified microcatheter, the galaxy g3 4mm x 12mm (gly120412/ 30737329) was inserted, and the physician felt resistance inside of the microcatheter.The galaxy g3 was withdrawn (gly120412/ 30737329).Both of the galaxy g3 3mm x 8mm (gly120308/30737323 and 30624688) were not able to be inserted into the microcatheter.Both coils were found to be broken.The procedure was completed with other new coils successfully.Continuous flush was done.Additional event information received on 14-may-2023 indicated that it was not necessary to remove or replace the microcatheter.Continuous flush on the microcatheter had been maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.Based on the product analysis of all three coils received, the embolic coil was found stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information was received indicating that a leonis mova (sb-kawasumi) microcatheter was used.Some coils were successfully used with the microcatheter prior to or after the encountered resistance.The introducer sheath seemed be fractured and could not insert into the microcatheter.It is unknown if excessive force was applied to the device, but the devices were used as usual and excessive force was believed not to be applied.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 4MM X 12CM
• 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: 17216550
• Report Number: 3008114965-2023-00434
• Device Sequence Number: 14998984
• Product Code: KRD
• UDI-Device Identifier: 10886704077480
• UDI-Public: 10886704077480
• 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): 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: 01/31/2025
• Device Model Number: GLY120412
• Device Catalogue Number: GLY120412
• Device Lot Number: 30737329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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 3MM X 8CM; GALAXY G3 3MM X 8CM; LEONIS MOVA (SB-KAWASUMI) MICROCATHETER; UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown