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

Model Number	GLM915040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization for an arteriovenous fistula (davf), a microcatheter was inserted and delivered to the lesion and coil embolization began.The 1.00mm x 3.00cm galaxy g3 mini (glm910030 / l14071) and the 1.50mm x 4.00cm galaxy g3 mini (glm915040 / l13976) were used and were re-sheathed.However, the introducer sheaths became damaged and the coils were no longer able to be used.The complaint coils were replaced with same size coils and the procedure was completed.It was not known if continuous flush was maintained.Additional information was received on 03-nov-2021.The information indicated that there was no resistance at any time during the coil advancement through the microcatheter.There was no report of any patient injury or adverse event.The complaint device was returned for evaluation.During the microscopic inspection of the returned device, the embolic coil was observed inside the introducer in a damaged condition.Based on the product analysis on 08-nov-2021, this event has been deemed mdr reportable as a ¿malfunction.¿.
Additional 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).[conclusion]: the healthcare professional reported that during a coil embolization for an arteriovenous fistula (davf), a microcatheter was inserted and delivered to the lesion and coil embolization began.The 1.00mm x 3.00cm galaxy g3 mini (glm910030 / l14071) and the 1.50mm x 4.00cm galaxy g3 mini (glm915040 / l13976) were used and were re-sheathed.However, the introducer sheaths became damaged and the coils were no longer able to be used.The complaint coils were replaced with same size coils and the procedure was completed.It was not known if continuous flush was maintained.Additional information was received on 03-nov-2021.The information indicated that there was no resistance at any time during the coil advancement through the microcatheter.There was no report of any patient injury or adverse event.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.50mm x 4.00cm galaxy g3 mini was received.Visual inspection was performed.The introducer is observed split at the area covering the distal portion of the device positioning unit (dpu) at the core wire section, causing the core wire to protrude.The core wire is also noted to be kinked.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.Under magnification, it is noted that the embolic coil is inside the introducer in damaged condition.Functional evaluation was precluded due to the condition of the returned complaint device.The dpu is protruding from the introducer and the embolic coil is damaged inside the introducer.A review of manufacturing documentation associated with this lot (l13976) 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following recommendation: do not fasten the rotating hemostasis valve (rhv) too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the micro coil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the micro coil as it passes through this transition.The complaint reported that the 1.50mm x 4.00cm galaxy g3 mini was one of two coils used during the coil embolization procedure of a davf.However, during resheathing, the introducer sheath became damaged and the coil could no longer be used.During visual inspection of the returned complaint device, introducer is observed split at the area covering the distal portion of the device positioning unit (dpu).The core wire was observed kinked and protruding from the introducer through the split observed.The kinked core wire protruding from the introducer through the split observed may be related to the reported issue that the coil introducer sheath was damaged during the resheathing; thus, the reported issue was confirmed.Microscopic inspection noted the embolic coil is still inside the introducer but is in a damaged condition.The damaged condition observed on the embolic coil under magnification may be a result of the attempt to resheath the coil; the exact cause of the damaged embolic coil cannot be conclusively determined.Coil damage 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 damage condition observed on the embolic coil under magnification was not originally reported / documented in the complaint.The embolic coil may have sustained the damage observed during microscopic inspection during the resheathing where it was reported that the sheath became damaged.The exact cause of the coil damage 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 1.50mm x 4.00cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in the damage 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00565.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
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 12791055
• Report Number: 3008114965-2021-00566
• Device Sequence Number: 14662641
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: L13976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• 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
• Patient Sex: Unknown