MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 5MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLY120515

Device Problems Failure to Advance (2524); Separation Failure (2547); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization of a gastroduodenal artery aneurysm, galaxy coils were used from the 8th coil.The first two coils, a galaxy g3 5mm x 15cm were placed without any problem.Then a galaxy g3 5mm x 15cm (gly120515, 30820687) was used.When the coil was placed in the aneurysm, it was inverted t and attempted to detach but could not.When pressed the release button on the control cable, no release sound was heard.The physician tried several times to push and pull the coil, but it could not be released.The coil was not detached even after the replacement of the datable box, the enpowercontrolcable (ecb00018200, 30960241) and the coil, but the issue continued.Therefore, a galaxy g3 5mm x 15cm (gly120515, 30817137) was pulled out.When this coil of the same size, was being inserted into the progreat 17 microcatheter (mc), strong resistance was felt inside the mc before the coil was into the vessel, so the coil was retrieved.The progreat 17 microcatheter was replaced with another new progreat 17.A new galaxy g3 5mm x 15cm was able to be inserted without any problem.Then two galaxy g3 5mm x 15cm (gly120515, 30666670) and (gly120515, 30860250) became stuck inside the mc and were retrieved.After that, the procedure was successfully completed with total 10 coils including 5 galaxy g3 coils implanted.The complaint coils and cable could not be received because already been discarded at the hospital.Four coils and one cable were the product in question.The order in which the coils were used is not clear.There was no negative impact to the patient.A continuous flush was done.Other concomitant devices are progreat 17 microcatheter, ecb000182-00.

Manufacturer Narrative

Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30820687 number, and no non-conformances related to the malfunction were identified.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 four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00439, 3008114965-2023-00440 and 3008114965-2023-00441.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that a pre-deployment electrical testing was performed with the coil that failed to detach.The coil was still attached to the delivery system when removed from the patient.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a coil embolization of a gastroduodenal artery aneurysm, galaxy coils were used from the 8th coil.The first two coils, a galaxy g3 5mm x 15cm were placed without any problem.Then a galaxy g3 5mm x 15cm (gly120515, 30820687) was used.When the coil was placed in the aneurysm, it was inverted t and attempted to detach but could not.When pressed the release button on the control cable, no release sound was heard.The physician tried several times to push and pull the coil, but it could not be released.The coil was not detached even after the replacement of the datable box, the enpowercontrolcable (ecb00018200, 30960241) and the coil, but the issue continued.Therefore, a galaxy g3 5mm x 15cm (gly120515, 30817137) was pulled out.When this coil of the same size, was being inserted into the progreat ¿17 microcatheter (mc), strong resistance was felt inside the mc before the coil was into the vessel, so the coil was retrieved.The progreat ¿17 microcatheter was replaced with another new progreat ¿17.A new galaxy g3 5mm x 15cm was able to be inserted without any problem.Then two galaxy g3 5mm x 15cm (gly120515, 30666670) and (gly120515, 30860250) became stuck inside the mc and were retrieved.After that, the procedure was successfully completed with total 10 coils including 5 galaxy g3 coils implanted.The complaint coils and cable could not be received because already been discarded at the hospital.Four coils and one cable were the product in question.The order in which the coils were used is not clear.There was no negative impact to the patient.A continuous flush was done.Other concomitant devices are progreat ¿17 microcatheter, ecb000182-00.Additional information received indicated that a pre-deployment electrical testing was performed with the coil that failed to detach.The coil was still attached to the delivery system when removed from the patient.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device and no non-conformances related to the malfunction were identified.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 events are related to the device manufacturing process.The exact cause of the events could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new 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.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
• Type of Device: 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: 17217762
• MDR Text Key: 318302691
• Report Number: 3008114965-2023-00438
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077510
• UDI-Public: 10886704077510
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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
• Device Operator: Health Professional
• Device Model Number: GLY120515
• Device Catalogue Number: GLY120515
• Device Lot Number: 30820687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENPOWER CONTROL CABLE; GALAXY G3 5MM X 15CM; GALAXY G3 5MM X 15CM; GALAXY G3 5MM X 15CM; THE PROGREAT 17 MICROCATHETER