MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM930040

Device Problems Fracture (1260); Difficult to Advance (2920)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.Initial reporter address line 1: (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.Preliminary photo images of the complaint device were captured by the j&j (b)(6)affiliates.The pre-shipment photos were reviewed by the product analysis lab team.[photo analysis]: based on the photos of the complaint device, it can be determined that the 3.00mm x 4.00cm galaxy g3 mini coil is in kinked condition.It was noted inside of the introducer still attached to the resistance heating (rh) coil.The device positioning unit (dpu) was also noted to be kinked.No other defects were noted.The reported issue related to the resistance between the detachable coil delivery system (dcs) and the microcatheter cannot be confirmed based on the photos.The issue related to the device positioning unit being fractured / with the polyethylene part torn off cannot be confirmed based on the photos; however, the kinked condition of the dpu may be related to this reported issue though this cannot be conclusively determined.Further investigation will be performed when the device is returned for analysis.A review of manufacturing documentation associated with this lot (l15549) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a coil embolization of an unruptured anterior communicating artery (acom) aneurysm, the target lesion was access with a guiding catheter, intermediate catheter and a microcatheter.The 3.00mm x 4.00cm galaxy g3 mini coil (glm930040 / l15549) was selected after the 5mm x 20cm target 360 soft coil (stryker) and a 4mm x 8cm axium prime 3d coil (medtronic).When the complaint coil was inserted in the sl-10® microcatheter (stryker) as per the instructions for use (ifu), there was strong resistance felt between the coil and the microcatheter along the way.When the coil was removed, the delivery wire in front of the coil joint was distorted and the polyethylene part was torn off.The complaint device was removed from the patient body.The 3mm x 4cm axium prime 3d coil was inserted and there was no resistance at all; it was delivered to the target lesion and detached.Next, the physician inserted a 2mm x 3cm target 360 nano coil which also did not encounter any resistance and was delivered to the target lesion and detached.The procedure was then completed.It was reported that there was continuous flush through the concomitant microcatheter.There was no report of any patient adverse event or complication.On (b)(6) 2021, preliminary photo images of the complaint device were captured by the j&j (b)(6) affiliates.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to include the additional event information received on 09-dec-2021.[additional information]: the healthcare professional reported that during a coil embolization of an unruptured anterior communicating artery (acom) aneurysm, the target lesion was access with a guiding catheter, intermediate catheter and a microcatheter.The 3.00mm x 4.00cm galaxy g3 mini coil (glm930040 / l15549) was selected after the 5mm x 20cm target 360 soft coil (stryker) and a 4mm x 8cm axium prime 3d coil (medtronic).When the complaint coil was inserted in the sl-10® microcatheter (stryker) as per the instructions for use (ifu), there was strong resistance felt between the coil and the microcatheter along the way.When the coil was removed, the delivery wire in front of the coil joint was distorted and the polyethylene part was torn off.The complaint device was removed from the patient body.The 3mm x 4cm axium prime 3d coil was inserted and there was no resistance at all; it was delivered to the target lesion and detached.Next, the physician inserted a 2mm x 3cm target 360 nano coil which also did not encounter any resistance and was delivered to the target lesion and detached.The procedure was then completed.It was reported that there was continuous flush through the concomitant microcatheter.There was no report of any patient adverse event or complication.On 18-nov-2021, preliminary photo images of the complaint device were captured by the j&j japan affiliates.On 09-dec-2021, additional information was received.The information confirmed that the target aneurysm was on the anterior communicating artery.There was no patient consequence nor patient injury associated with the reported issue.There was also no delay in the procedure.The coil was removed from the patient; the microcatheter was not removed.E.1: the initial reporter phone: (b)(6) the initial reporter email address was not available / reported.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 that the product analysis lab received the complaint device on (b)(6) 2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, 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 report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a coil embolization of an unruptured anterior communicating artery (acom) aneurysm, the target lesion was access with a guiding catheter, intermediate catheter and a microcatheter.The 3.00mm x 4.00cm galaxy g3 mini coil (glm930040 / l15549) was selected after the 5mm x 20cm target 360 soft coil (stryker) and a 4mm x 8cm axium prime 3d coil (medtronic).When the complaint coil was inserted in the sl-10® microcatheter (stryker) as per the instructions for use (ifu), there was strong resistance felt between the coil and the microcatheter along the way.When the coil was removed, the delivery wire in front of the coil joint was distorted and the polyethylene part was torn off.The complaint device was removed from the patient body.The 3mm x 4cm axium prime 3d coil was inserted and there was no resistance at all; it was delivered to the target lesion and detached.Next, the physician inserted a 2mm x 3cm target 360 nano coil which also did not encounter any resistance and was delivered to the target lesion and detached.The procedure was then completed.It was reported that there was continuous flush through the concomitant microcatheter.There was no report of any patient adverse event or complication.On 18-nov-2021, preliminary photo images of the complaint device were captured by the j&j japan affiliates.Preliminary photo images of the complaint device were captured by the j&j japan affiliates.The pre-shipment photos were reviewed by the product analysis lab team.[photo analysis]: based on the photos of the complaint device, it can be determined that the 3.00mm x 4.00cm galaxy g3 mini coil is in kinked condition.It was noted inside of the introducer still attached to the resistance heating (rh) coil.The device positioning unit (dpu) was also noted to be kinked.No other defects were noted.The reported issue related to the resistance between the detachable coil delivery system (dcs) and the microcatheter cannot be confirmed based on the photos.The issue related to the device positioning unit being fractured / with the polyethylene part torn off cannot be confirmed based on the photos; however, the kinked condition of the dpu may be related to this reported issue though this cannot be conclusively determined.Further investigation will be performed when the device is returned for analysis.A review of manufacturing documentation associated with this lot (l15549) 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.On 09-dec-2021, additional information was received.The information confirmed that the target aneurysm was on the anterior communicating artery.There was no patient consequence nor patient injury associated with the reported issue.There was also no delay in the procedure.The coil was removed from the patient; the microcatheter was not removed.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 3.00mm x 4.00cm galaxy g3 mini coil was received.Visual inspection was performed.The embolic coil component was received inside the introducer still attached to the resistance heating (rh) coil.There were no kinks, no damages observed on the introducer.Microscopic inspection was performed.Under magnification, the embolic coil component is observed damaged and in a ¿wavy¿ condition.Stretched sections can be observed on the embolic coil.The core wire was noted to be slightly kinked.Functional evaluation and analysis could not be performed due to the condition of the embolic coil and the core wire.The complaint documented that during a coil embolization targeting an unruptured anterior communicating artery (acom) aneurysm, the target lesion was access with a guiding catheter, intermediate catheter and a microcatheter.The 3.00mm x 4.00cm galaxy g3 mini coil was chosen after the implantation of two competitor coils.When the complaint coil was inserted in the sl-10® microcatheter (stryker) as per the ifu, there was strong resistance felt between the coil and the microcatheter along the way.When the coil was removed, the delivery wire in front of the coil joint was distorted and the polyethylene part was torn off.The visual analysis of the returned sample determined that embolic coil was returned inside the introducer and still attached to the rh coil.No visual damages were observed on the introducer.The findings during the visual inspection is consistent with the observation made during the photo analysis.Additionally, a microscopic inspection was performed, and embolic coil was found damaged, and some sections stretched.Core wire was found slightly kinked.Although failure could not be replicated, damages observed and documented in the complaint could be the result of device maneuvering during the procedure.Therefore, the reported issue has been confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.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) contains the following recommendations: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.If unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1 in (2-3 cm).If unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.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 3MM 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: 12934041
• MDR Text Key: 289693564
• Report Number: 3008114965-2021-00586
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080329
• UDI-Public: 10886704080329
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: GLM930040
• Device Catalogue Number: GLM930040
• Device Lot Number: L15549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• 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: 8F SHEATH INTRODUCER; 8FR OPTIMO GUIDING CATHETER (TOKAI MEDICAL); CHIKAI 14 GUIDEWIRE (ASAHI INTECC); CO-PILOT Y CONNECTOR (ABBOTT); ENPOWER CONTROL CABLE; SHORYU BALLOON CATHETER (KANEKA MEDIX); SL-10® MICROCATHETER (STRYKER)