MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM920060

Device Problem Failure to Advance (2524)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during a coil embolization procedure targeting an 8mm internal carotid artery-posterior communicating artery (icpc) aneurysm, competitor coils were used for framing and filling.The complaint coil, a 2.00mm x 6.00cm galaxy g3 mini (glm920060 / l14654) was used as the fourth coil, but it was not able to be delivered and the coil part was impeded.The complaint coil was removed and replaced with another coil of the same size and the procedure was completed.It was reported that continuous flush was maintained through the concomitant sl-10® microcatheter (stryker).Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end at the slit of the clear tube.There was no report of any patient adverse event or complication.The complaint devices were returned for evaluation and analysis.During the microscopic inspection of the 2.00mm x 6.00cm galaxy g3 mini, the embolic coil was observed to be stretched condition.Based on the product analysis on 27 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 email address is not reported / available.[conclusion]: the healthcare professional reported that during a coil embolization procedure targeting an 8mm internal carotid artery-posterior communicating artery (icpc) aneurysm, competitor coils were used for framing and filling.The complaint coil, a 2.00mm x 6.00cm galaxy g3 mini (glm920060 / l14654) was used as the fourth coil, but it was not able to be delivered and the coil part was impeded.The complaint coil was removed and replaced with another coil of the same size and the procedure was completed.It was reported that continuous flush was maintained through the concomitant sl-10® microcatheter (stryker).Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end at the slit of the clear tube.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 2.00mm x 6.00cm galaxy g3 mini was received.Visual inspection was performed.The device was observed in good normal condition.No appearance of damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.The embolic coil is observed stuck inside the introducer in stretched condition.This observation of the stretched condition of the embolic coil is likely related to the reported issue in the complaint that the coil could not be delivered and was impeded.The exact cause of the stretched condition of the embolic coil cannot be conclusively determined.Procedure and other factors may have contributed to the observed condition.Based on the condition of the embolic coil, the reported issue is confirmed.Functional test could not be performed due to the embolic coil being stuck inside the introducer in stretched condition.A review of manufacturing documentation associated with this lot (l14654) 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 stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.The exact cause of the stretched condition of the coil cannot be conclusively determined; however, it is possible that during when the coil became impeded in the microcatheter, some force was inadvertently applied to the device which resulted in the coil becoming stretched.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 2.00mm x 6.00cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in stretched 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 2MM X 6CM
• 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: 13090975
• MDR Text Key: 284975596
• Report Number: 3008114965-2021-00780
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: 10886704080312
• 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: 12/27/2021

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: 12/31/2021
• Device Model Number: GLM920060
• Device Catalogue Number: GLM920060
• Device Lot Number: L14654
• 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: 12/27/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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: 6FR FUBUKI GUIDE CATHETER (ASAHI INTECC); SL-10® MICROCATHETER (STRYKER)