MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910020
Medical Device Problem Codes	Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization to the arterial conica, the physician felt some resistance with a galaxy g3 mini coil 1mm x 2cm (glm910020, 30683263) during the process of delivering coil to the echolon10 microcatheter (mc).When the coil was in the target position, the doctor tried to detach coil, but the coil was unable to detach.A new coil was switched to complete the surgery.There was no patient injury report.It was not necessary to remove or replace the microcatheter.The device did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.
Additional Manufacturer Narrative
Product complaint (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to the arterial conica, the physician felt some resistance with a galaxy g3 mini coil 1mm x 2cm (glm910020, 30683263) during the process of delivering coil to the echolon10 microcatheter (mc).When the coil was in the target position, the doctor tried to detach coil, but the coil was unable to detach.A new coil was switched to complete the surgery.There was no patient injury report.It was not necessary to remove or replace the microcatheter.The device did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No additional information is available.The device was discarded, therefor, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30683263 number, 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 event is related to the device manufacturing process.The exact cause of the event 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.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.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 events were 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 # (b)(4).Complaint conclusion updated with product analysis: as reported by the field, during a coil embolization to the arterial conica, the physician felt some resistance with a galaxy g3 mini coil 1mm x 2cm (glm910020, 30683263) during the process of delivering coil to the echolon10 microcatheter (mc).When the coil was in the target position, the doctor tried to detach coil, but the coil was unable to detach.A new coil was switched to complete the surgery.There was no patient injury report.It was not necessary to remove or replace the microcatheter.The device did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No additional information is available.A non-sterile galaxy g3 mini 1mm x 2cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the core wire was found with multiple kinked conditions along its entire length.Some residues of dry blood were found inside the introducer.No other damages or anomalies were observed on the device during the visual inspection.Under microscopic magnification, the embolic coil was found to be stretched, and it remained inside the introducer.Also, the blue fiber was noted to be exposed.The embolic coil was noted to be still attached to the resistance heating (rh).The electrical resistance of the galaxy g3 mini 1mm x 2cm device was measured with a multimeter initially measured 50.9 ohms o, which is within the specification.Lso, the device was connected to a lab sample detachment control box dcb00000500 (dcb) and a lab sample enpower control cable and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed, and a beep sound was heard.The customer complaint regarding a failure to detach was not confirmed since the resistance heating (rh) was heated and the coil was successfully detached from the unit.The customer complaint regarding resistance could not be evaluated through functional testing; however, the appearance of the core wire confirms that excessive force was applied, as a result of the resistance felt during the procedure.The kinked conditions found in the core wire are considered secondary to the impeded condition encountered during the procedure.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.Stretching can occur during procedure handling where force may have been inadvertently applied.It is possible that an adequate flush had not been done; without an adequate flush, issues such as resistance between the coil and the microcatheter can arise, which may cause some force to be inadvertently exerted on the device when the coil was pushed and then retracted, which can result in the coil becoming stretched.Based on this, the customer complaint regarding the resistance condition was confirmed.There is no indication that the issue reported in the complaint 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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do 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, re sheathing the microcoil system, and replace it with a new microcoil system.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 events were 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 MINI 1MM 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15870247
• Report Number: 3008114965-2022-00771
• Device Sequence Number: 6689439
• Product Code: KRD
• UDI-Device Identifier: 10886704080237
• UDI-Public: 10886704080237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2023

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: 10/31/2024
• Device Model Number: GLM910020
• Device Catalogue Number: GLM910020
• Device Lot Number: 30683263
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/05/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: ECHOLON10 MICROCATHETER
• Patient Sex: Unknown