MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM915040

Device Problem Separation Failure (2547)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14569) would not detach after the detachment button was pressed twice.The hub did not get wet.There was no report of any patient injury or complication.On 09 dec 2021, additional information was received.The information indicated that the coil was successfully removed from the patient; it was still attached to the delivery system when it was removed.The complaint coil was used with a headway® duo microcatheter (microvention).The information also indicated that the physician used the headway duo microcatheter, which is ¿.0165 but tapers to.013 tip¿ and this may have been what caused the issue with the coil not detaching.It was reported that the green system ready light was illuminated and during the detachment cycle, the detachment light illuminate and the audible signal beep was heard.The same microcatheter was not used to complete the procedure.The procedure was completed using a new microcatheter and coil.

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The phone and email address of the initial reporter are not available / reported.The product was received by cerenovus product analysis lab on 10-dec-2021.The returned product is pending evaluation; when the product investigation has been completed, a supplemental 3500a report will be submitted.A review of manufacturing documentation associated with this lot (l14569) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14569) would not detach after the detachment button was pressed twice.The hub did not get wet.There was no report of any patient injury or complication.On 09 dec 2021, additional information was received.The information indicated that the coil was successfully removed from the patient; it was still attached to the delivery system when it was removed.The complaint coil was used with a headway® duo microcatheter (microvention).The information also indicated that the physician used the headway duo microcatheter, which is ¿.0165 but tapers to.013 tip¿ and this may have been what caused the issue with the coil not detaching.It was reported that the green system ready light was illuminated and during the detachment cycle, the detachment light illuminate and the audible signal beep was heard.The same microcatheter was not used to complete the procedure.The procedure was completed using a new microcatheter and coil.The complaint product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.50mm x 4.00cm galaxy g3 mini coil was received inside the concomitant headway® duo microcatheter.The complaint device was stuck inside the microcatheter; the microcatheter had to be removed.The complaint coil was visually inspected and it was observed in normal, good condition.There was no damage nor anomaly observed during the visual inspection.Microscopic inspection was performed.Under magnification, the resistance heating (rh) coil showed evidence that it had been heated.The distal outer sheath was observed melted; an indication that the detachment process was initiated.The embolic coil component was not returned.Functional testing: the resistance of the 1.50mm x 4.00cm galaxy g3 mini was measured with a multimeter.The resistance was measured to be 52.0 o; this is within the specification range of 48.5 o ¿ 56.0 o.The device was then connected to a detachment control box with a lab sample enpower control cable and the power was turned on.The system ready light became illuminated.A review of manufacturing documentation associated with this lot (l14569) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: 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.The complaint documented that during the procedure, the complaint coil would not detach after the detachment button was pressed twice.The green system ready light was illuminated and the audible signal beep was heard, but the coil failed to detach.The complaint device was returned without the embolic coil component.The rh coil showed evidence of being heated, this is consistent with what was reported in the complaint.Even though the embolic coil component was not returned for evaluation, the functional test was performed without difficulty.The complaint device was connected to a detachment control box and a lab sample enpower control cable.The power was turned on and the system ready light illuminated.Based on the finding, the reported issue that the complaint coil failed to detach could not be confirmed.Procedural factors may have contributed to the reported issue since there was no damage observed on the device.A manufacturing documentation review was performed and there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to update the device investigation.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the 1.50mm x 4.00cm galaxy g3 mini coil (glm915040 / l14569) would not detach after the detachment button was pressed twice.The hub did not get wet.There was no report of any patient injury or complication.On 09 dec 2021, additional information was received.The information indicated that the coil was successfully removed from the patient; it was still attached to the delivery system when it was removed.The complaint coil was used with a headway® duo microcatheter (microvention).The information also indicated that the physician used the headway duo microcatheter, which is ¿.0165 but tapers to.013 tip¿ and this may have been what caused the issue with the coil not detaching.It was reported that the green system ready light was illuminated and during the detachment cycle, the detachment light illuminate and the audible signal beep was heard.The same microcatheter was not used to complete the procedure.The procedure was completed using a new microcatheter and coil.The complaint product was returned and received for evaluation and analysis.The updated investigation is documented below.[updated investigation summary]: a non-sterile 1.50mm x 4.00cm galaxy g3 mini coil was received inside the concomitant headway® duo microcatheter.The complaint device was stuck inside the microcatheter; the microcatheter had to be removed.The complaint coil was visually inspected and it was observed in normal, good condition.There was no damage nor anomaly observed during the visual inspection.Microscopic inspection was performed.Under magnification, the resistance heating (rh) coil showed evidence that it had been heated.The distal outer sheath was observed melted; an indication that the detachment process was initiated.The embolic coil component was not returned.Functional testing: the resistance of the 1.50mm x 4.00cm galaxy g3 mini was measured with a multimeter.The resistance was measured to be 52.0 o; this is within the specification range of 48.5 o ¿ 56.0 o.The device was then connected to a detachment control box with a lab sample enpower control cable and the power was turned on.The system ready light became illuminated.A review of manufacturing documentation associated with this lot (l14569) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Per the instructions for use (ifu), proper selection of the appropriately sized microcatheter is required to avoid damage to the microcoil system and to minimize potential complications.Microcatheter selection is also determined by the physician and is predicated by the location of the aneurysm, patient safety, and physician preference.To ensure proper placement and detachment of the microcoil, the selected microcatheter must have two (2) radiopaque tip markers three (3) cm apart.The galaxy g3 mini microcoil system is compatible with microcatheters with inner lumen diameters ranging from 0.0165 to 0.017 in (0.419 to 0.432 mm).Per the additional information provided in the complaint, the microcatheter used was a headway duo, which is 0.0165 but tapers to 0.013 tip.It is possible that due to the tapering tip of the headway duo microcatheter, it may not be compatible with the complaint coil used.The complaint documented that during the procedure, the complaint coil would not detach after the detachment button was pressed twice.The green system ready light was illuminated and the audible signal beep was heard, but the coil failed to detach.The complaint device was returned without the embolic coil component.The rh coil showed evidence of being heated, this is consistent with what was reported in the complaint.Even though the embolic coil component was not returned for evaluation, the functional test was performed without difficulty.The complaint device was connected to a detachment control box and a lab sample enpower control cable.The power was turned on and the system ready light illuminated.Based on the finding, the reported issue that the complaint coil failed to detach could not be confirmed.Procedural factors may have contributed to the reported issue since there was no damage observed on the device.A manufacturing documentation review was performed and there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: GALAXY G3 MINI 1.5MM X 4CM
• 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 ; 949789-868
• MDR Report Key: 13006435
• MDR Text Key: 283788998
• Report Number: 3008114965-2021-00617
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

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 Expiration Date: 12/31/2021
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: L14569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 01/14/2022
• Supplement Dates FDA Received: 01/06/2022; 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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: HEADWAY® DUO (MICROVENTION)