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

Model Number	GLM915020
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a 1.5mm x 2cm galaxy g3 mini coil (glm915020, 30412527) did not detach after more than 10 times of detachment try.The physician successfully took the device out of the patient's body.The detachment cable was changed two times.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr 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).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 1.5mm x 2cm galaxy g3 mini coil (glm915020, 30412527) did not detach after more than 10 times of detachment try.The physician successfully took the device out of the patient's body.The detachment cable was changed two times.There was no patient injury reported.No additional information is available.A non-sterile unit galaxy g3 mini 1.5mm x 2cm was received inside of a pouch at cerenovus for evaluation.The device was visually inspected, and it was found in good normal conditions.However, the embolic coil was not returned for evaluation with the rest of the device, and it was found kinked at 1 and 162 cm from proximal.Also, the marker band was found at 37 cm from hub, and it was found within specification.The device was inspected under microscope and it was noted that the rh is heated, and the embolic coil was not returned for analysis.A functional test could not be performed due the embolic coil was detached from the device and not returned for evaluation, also the rh was found heated.A manufacturing record evaluation (mre) was performed for the finished device 30412527 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual inspection and microscopic examination of the returned device.The visual analysis of the returned sample determined that the embolic coil was not returned for analysis, also the rh was found heated.The functional test could not be performed due to the conditions in which the device was returned for evaluation.The reported customer complaint of ¿coil ¿ failure to detach¿ could not be confirmed.Based on the information currently available, microscopic examination of the returned product found that the rh is heated, the heated condition suggest that the detachment cycle was performed, and this is related with the detached condition noted on the device.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Neither the mre nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.The instructions for use (ifu) do contain the following directions for use: 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.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of 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
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11657203
• Report Number: 3008114965-2021-00149
• Device Sequence Number: 4224617
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 06/30/2023
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30412527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTING CABLE