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

Model Number	GLM915040
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, the coil pusher of a galaxy g3 mini coil 1.5mm x 4cm (glm915040, 30360503) is kinked.No patient injury was reported.Based on the visual analysis of the device pictures received, the core wire was found broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the visual analysis on the pictures received.Based on the visual analysis, the core wire was found broken.The findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.Based on the visual analysis of the pictures received, it could be noted that the dpu of the galaxy g3 mini 1.5mm x 4cm has multiple kinks.Also, it could be noted that the core wire is fraying and is severely damaged.No other defects could be noted.A manufacturing record evaluation (mre) was performed for the finished device 30360503 number, and no non-conformances related to the reported complaint condition were identified.The reported condition "device positioning unit (thermo-mechanical detachment system)- kinked/bent" was confirmed since the dpu of the galaxy could be noted with several kinked conditions.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, the coil pusher of a galaxy g3 mini coil 1.5mm x 4cm (glm915040, 30360503) is kinked.No patient injury was reported.No additional information is available.A non-sterile unit galaxy g3 mini 1.5mm x 4cm was received inside of a pouch.The device was visually inspected, and a kink was noticed near the connector, at 29.5 and 41 inches from the proximal end.Copper wires from the core wire were noted to be broken at 10 inches from the proximal end.Reddish residues were observed at the embolic coil.The embolic coil was inspected, and it was found to be kinked and stretched at several sections.More reddish residues were observed along embolic coil length.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the complaint were found during the review.The device was returned to cerenovus for further evaluation.During the visual and microscopic analysis of the device, it was noted that the core wire had a kink near the connector and several kinks throughout its length at 29.5 and 41 inches from the proximal end.Additionally, copper wires from the core wire were noted to be broken at 10 inches from the proximal end.Embolic coil was inspected, and it was observed kinked and stretched with reddish residues.The customer complaint was confirmed due to the damages observed are consistent with the picture provided by the customer.Reddish residues observed reasonably suggest that intraprocedural factors may have contributed to the failure, however this cannot be conclusively determined based on the information available.A manufacturing record evaluation was performed, and no non-conformances were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following recommendation: ¿ 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• 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 ; 9497898687
• MDR Report Key: 12968268
• Report Number: 3008114965-2021-00649
• Device Sequence Number: 11860823
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: 30360503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2020
• 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