MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 8MM X 24CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120824
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization for subarachnoid hemorrhage (sah), an 8mm x 24cm galaxy g3 coil (gly120824, 30470359) was inserted and delivered to the lesion.The complaint coil was re-sheathed a few times but got prematurely detached even though the detachment cycle was not performed.There were no post-procedure changes in the patient.The complaint coil was inserted despite premature detachment.After that, three coils were implanted, and the procedure was completed.A continuous flush was not done.The lesion was the internal carotid-posterior communicating artery (ic-pc).Other concomitant devices are unknown.
Additional Manufacturer Narrative
Product complaint (b)(4).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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30470359 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that there was no additional intervention.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a coil embolization for subarachnoid hemorrhage (sah), an 8mm x 24cm galaxy g3 coil (gly120824, 30470359) was inserted and delivered to the lesion.The complaint coil was re-sheathed a few times but got prematurely detached even though the detachment cycle was not performed.There were no post-procedure changes in the patient.The complaint coil was inserted despite premature detachment.After that, three coils were implanted, and the procedure was completed.A continuous flush was not done.The lesion was the internal carotid-posterior communicating artery (ic-pc).Other concomitant devices are unknown.Additional information received indicated that there was no additional intervention.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30470359 number, and no non-conformances related to the malfunction were identified.Premature detachment is a known potential procedural complication associated with the galaxy g3 coil.The galaxy g3 ifu cautions that if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.The microcoil system should be gently removed.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 8MM X 24CM
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15579946
• Report Number: 3008114965-2022-00651
• Device Sequence Number: 6460688
• Product Code: KRD
• UDI-Device Identifier: 10886704077589
• UDI-Public: 10886704077589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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): 11/17/2022

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: 10/31/2023
• Device Model Number: GLY120824
• Device Catalogue Number: GLY120824
• Device Lot Number: 30470359
• 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: 09/25/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 11/17/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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