MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM915020

Device Problem Separation Failure (2547)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a coil embolization, a galaxy g3 mini 1.5mm x 2cm coil (glm915020, 30558128) was being used as the first filling coil during the procedure.When the coil was completely filled in the aneurysm, it cannot be detached after connecting detachment box and a new cable.The physician checked battery and found it had enough power, removed the coil outside of patient body and it was found to be detached in the operating table.A competitor¿s coil was used to complete the surgery.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a galaxy g3 mini 1.5mm x 2cm coil (glm915020, 30558128) was being used as the first filling coil during the procedure.When the coil was completely filled in the aneurysm, it cannot be detached after connecting detachment box and a new cable.The physician checked battery and found it had enough power, removed the coil outside of patient body and it was found to be detached in the operating table.A competitor¿s coil was used to complete the surgery.There was no patient injury reported.No additional information is available.A galaxy g3 mini 1.5mm x 2cm was received contained in a pouch.Visual inspection was performed.The embolic coil component was not received for evaluation.The rest of the device showed no damage.The device was inspected under magnification, the distal part of the resistance heating coil (rh) appeared wavy showing slight traces that it had been subjected to heat.The detachment fiber was open.Additionally, the electrical resistance of the returned device measured and was within specifications.The dpu (delivery positioning unit) was connected to a dcb (detachment control box) lab sample and the system ready light illuminated.However, the detachment cycle could not be attempted since the embolic coil was not returned.A manufacturing record evaluation was performed for the finished device 30558128 number, and no non-conformances related to the malfunction were identified.The galaxy g3 mini 1.5mm x 2cm was received contained in a pouch.The embolic coil component was not received for evaluation.The rest of the device showed no damage.Microscopic inspection was performed.Under magnification, the distal part of the resistance heating coil (rh) appeared wavy showing slight traces that it had been subjected to heat.The detachment fiber was open; this suggests that the detachment cycle was initiated which resulted in the detachment of the embolic coil.The electrical resistance of the returned device was measured and found to be within specifications.The dpu (delivery positioning unit) was connected to a dcb (detachment control box) lab sample and the system ready light illuminated.However, the detachment cycle could not be attempted since the embolic coil was not returned.The customer complaint could not be confirmed since the evidence suggest that the coil became detached after the detachment cycle was initiated.No contributing factors were identified from the returned device.A manufacturing record evaluation was performed, and no non-conformances related to the complaint were found during the review.Failure to detach is a known potential issue associated with the use of this device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains 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.- if the system is free of faults, depress the detach button on the enpower dcb or the enpower control cable.The detach cycle light next to the button will illuminate and an intermittent tone will sound for the duration of the detachment cycle.If the light and audible tone do not activate, replace the dcb.- after the light goes out and the tone stops, detachment of the microcoil from the dpu wire must be fluoroscopically verified by gently withdrawing the dpu wire back approximately one (1) mm.Observe if the microcoil has detached.A manufacturing record evaluation was performed for the finished device 30558128 number, and no non-conformances related to the malfunction were identified.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: GALAXY G3 MINI 1.5MM X 2CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13017669
• MDR Text Key: 289739939
• Report Number: 3008114965-2021-00684
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30558128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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