MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 2.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY122505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, an unspecified microcatheter (mc) was in place and a galaxy g3 2.5mm x 5cm coil (gly122505, 30757518) was delivered to target site.The coil was filled in the aneurysm and tried to detach, but the coil was unable to detach.The physician inspected indicator light of the detachment box and connect cable, and observed all were under good condition.Doctor pressed the detachment button to detach the coil again, but the coil still failed to detach.Then retracted the coil and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional event information received on 30-jan-2024 indicated that a pre-deployment electrical testing was not performed.The same dcb and cable were used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.There were no procedural delays due to the event.
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).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, an unspecified microcatheter (mc) was in place and a galaxy g3 2.5mm x 5cm coil (gly122505, 30757518) was delivered to target site.The coil was filled in the aneurysm and tried to detach, but the coil was unable to detach.The physician inspected indicator light of the detachment box and connect cable, and observed all were under good condition.Doctor pressed the detachment button to detach the coil again, but the coil still failed to detach.Then retracted the coil and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional event information received on 30-jan-2024 indicated that a pre-deployment electrical testing was not performed.The same dcb and cable were used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.There were no procedural delays due to the event.A non-sterile galaxy g3 2.5mm x 5cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages was observed.A microscopical inspection revealed that the embolic coil was still attached to the resistance heating (rh) and it was found in good normal condition.The distal outer sheath had not been softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process was not initiated.The electrical resistance of the galaxy g3 was measured with a multimeter, and no values were obtained.Also, the device was connected to a lab sample detachment control box (dcb) dcb00000500, and the power was turned on.The system ready light was not illuminating.A manufacturing record evaluation was performed for the finished device 30757518 number, and no non-conformances related to the malfunction were identified.The device history records (dhr) for lot number 30757518 were reviewed and no evidence of deficiencies during the manufacturing process was found.No non-conformances were generated during the manufacturing process.The issue reported regarding the detach cycle light not illuminating was confirmed.The device did not present any physical damage (cuts or severe kinks) to the shaft of the device positioning unit (dpu) to cause electrical issues.Another place for electrical issues would be at either connection point ¿ at the proximal connector where the pins are soldered or at the distal connection near to or inside the rh heater, however, all components were inspected, and no anomalies were observed.It is possible that other factors such as device manipulation, may have caused the electrical failure that led to the failure to detach.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% electrical continuity test for finished product prior to pouching and boxing to prevent failure to detach from occurring during the procedure.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 product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ verify that the microcoil delivery system is fully connected and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re sheathing the microcoil system, and replace with a new microcoil 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.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4) updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 2.5MM X 5CM
• 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: 18617561
• Report Number: 3008114965-2024-00165
• Device Sequence Number: 7565790
• Product Code: KRD
• UDI-Device Identifier: 10886704077411
• UDI-Public: 10886704077411
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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: 02/28/2025
• Device Catalogue Number: GLY122505
• Device Lot Number: 30757518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/16/2024; 03/06/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/01/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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: ENPOWER CONTROL CABLE; MICROCATHETER (UNSPECIFIED BRAND); UNK DETACHMENT CONTROL BOX
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian