MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.5MM X 4.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM925045
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Lot ¿ not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization of an aneurysm at the anterior communicating artery (acom), four unspecified coils were implanted and the complaint coil, a galaxy g3 mini 2.5mm x 4.5cm (glm925045, lot unknown) was used.This coil was inserted and detached.The physician removed the delivery wire but the coil part was attached to the delivery wire.After that, the delivery wire was pushed further but the coil part was detached.An unspecified coil was added, and the procedure was completed.It was unclear if a continuous flush was done.No patient injury was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated section on this medwatch report: b4, g3, g6, h2, h3 h6 and h10.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, during a coil embolization of an aneurysm at the anterior communicating artery (acom), four unspecified coils were implanted and the complaint coil, a galaxy g3 mini 2.5mm x 4.5cm (glm925045, lot unknown) was used.This coil was inserted and detached.The physician removed the delivery wire but the coil part was attached to the delivery wire.After that, the delivery wire was pushed further but the coil part was detached.An unspecified coil was added, and the procedure was completed.It was unclear if a continuous flush was done.No patient injury was reported.Additional information received indicated that there was no coil positioning difficulty reported.The coil was detached inside the aneurysm by pushing delivery wire.The coil was positioned inside the aneurysm.No neck remodeling was utilized.No excessive force was applied to the device.The device was implanted; therefore, no further analysis can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Entanglement is a known potential issue associated with the use of the device.The ifu contains instructions and cautions regarding proper placement of the device, including introduction and positioning of the microcoil.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that there was no coil positioning difficulty reported.The coil was detached inside the aneurysm by pushing delivery wire.The coil was positioned inside the aneurysm.No neck remodeling was utilized.No excessive force was applied to the device.Section e1 - initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 2.5MM X 4.5CM
• 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: 12518636
• Report Number: 3008114965-2021-00474
• Device Sequence Number: 14529763
• Product Code: KRD
• UDI-Device Identifier: 10886704080275
• UDI-Public: 10886704080275
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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 Model Number: GLM925045
• Device Catalogue Number: GLM925045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 12/24/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/18/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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