MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM910040

Device Problem Difficult to Advance (2920)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during a coil embolization procedure targeting an aneurysm on the middle cerebral artery (mca), a concomitant sl-10® microcatheter (stryker) was inserted and the coil embolization was started.A competitor coil was used as the firs coil and the 1.00mm x 4.00cm galaxy g3 mini coil (glm910040 / 30485178) was the second coil used.There was resistance felt when the complaint coil was inserted into the microcatheter.The physician judged that it was difficult to continue with the procedure.The complaint coil was replaced with another coil and the procedure was completed.It was reported that the complaint coil was prepped and used as per the instructions for use (ifu).Continuous flush was maintained through the microcatheter.There was no report of any patient adverse event or complication.On 09 nov 2021, additional information was received.The information indicated that the complaint coil was able to be removed through the microcatheter without removing the microcatheter from the target lesion.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.Excessive force was not applied to the device.The complaint device was returned for evaluation.During the microscopic inspection of the returned device, the embolic coil was observed in damaged condition.Based on the product analysis on 03-dec-2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.(b)(6).The initial reporter email address is not reported.[conclusion]: the healthcare professional reported that during a coil embolization procedure targeting an aneurysm on the middle cerebral artery (mca), a concomitant sl-10® microcatheter (stryker) was inserted and the coil embolization was started.A competitor coil was used as the firs coil and the 1.00mm x 4.00cm galaxy g3 mini coil (glm910040 / 30485178) was the second coil used.There was resistance felt when the complaint coil was inserted into the microcatheter.The physician judged that it was difficult to continue with the procedure.The complaint coil was replaced with another coil and the procedure was completed.It was reported that the complaint coil was prepped and used as per the instructions for use (ifu).Continuous flush was maintained through the microcatheter.There was no report of any patient adverse event or complication.On 09 nov 2021, additional information was received.The information indicated that the complaint coil was able to be removed through the microcatheter without removing the microcatheter from the target lesion.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.Excessive force was not applied to the device.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.00mm x 4.00cm galaxy g3 mini coil was received.Visual inspection was performed.It was observed to be in good, normal condition.There were no appearance of damages nor anomalies noted during the visual inspection.Microscopic inspection was performed.Under magnification, the embolic coil was observed stuck inside the introducer in damaged condition.Functional evaluation could not be performed due to the embolic coil being stuck inside the introducer and in damaged condition.The damaged condition of the embolic coil observed under microscopic inspection is related to the reported issue in the complaint that the device encountered resistance when it was being inserted into the microcatheter.Procedural factors and other factors such as device interaction and device manipulation may have contributed to the observed damaged condition of the coil; however the exact cause cannot be conclusively determined.The observation that the coil is damaged confirmed the reported issue in the complaint.A review of manufacturing documentation associated with this lot (30485178) 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 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.¿ never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.Refer to coil retrieval.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.Coil damaged is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as coil damage from occurring.The damaged condition observed on the embolic coil under magnification was not originally reported may have been related to other factors; the exact cause cannot be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.00mm x 4.00cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in the damaged condition.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.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.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 1MM 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: 12926070
• MDR Text Key: 283671316
• Report Number: 3008114965-2021-00622
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080251
• UDI-Public: 10886704080251
• 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
• Report Date: 12/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: GLM910040
• Device Catalogue Number: GLM910040
• Device Lot Number: 30485178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• 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: CHIKAI 14 NEUROVASCULAR GUIDEWIRE (ASAHI INTECC); ENPOWER CONTROL CABLE; SL-10® MICROCATHETER (STRYKER)