MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3.5MM X 9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY123509
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30710693 number, and no non-conformances related to the malfunction were identified.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.
Event or Problem Description
As reported by the field, during a coil embolization for unruptured middle cerebral artery aneurysm, a 3.5mm x 9cm galaxy g3 coil (gly123509, 30710693) was used as the first coil.However, the coil did not fit the aneurysm wall.The complaint coil was re-sheathed but became unraveled.The complaint coil was removed together with an unspecified microcatheter (exselsior sl10) which had been delivered to the aneurysm.After that, the same microcatheter was inserted and advanced.The complaint coil was replaced with another coil and the procedure was completed after coiling embolization.A continuous flush was done.
Additional Manufacturer Narrative
Product complaint(b)(4).Section b5: additional information was received indicating that there was no resistance encountered during the use of the device.There was no excessive force used at anytime with the device.An adequate flush was maintained through the devices.There was no procedural delays due to the event.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a coil embolization for unruptured middle cerebral artery aneurysm, a 3.5mm x 9cm galaxy g3 coil (gly123509, 30710693) was used as the first coil.However, the coil did not fit the aneurysm wall.The complaint coil was re-sheathed but became unraveled.The complaint coil was removed together with a microcatheter (exselsior sl10) which had been delivered to the aneurysm.After that, the same microcatheter was inserted and advanced.The complaint coil was replaced with another coil and the procedure was completed after coiling embolization.A continuous flush was done.Additional information was received indicating that there was no resistance encountered during the use of the device.There was no excessive force used at anytime with the device.An adequate flush was maintained through the devices.There was no procedural delays due to the event.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30710693 number, and no non-conformances related to the malfunction were identified.Coil unraveled is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Unraveled can occur during procedure handling where force may have been inadvertently applied.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 review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 events were 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 3.5MM X 9CM
• 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: 15274860
• Report Number: 3008114965-2022-00550
• Device Sequence Number: 16834844
• Product Code: KRD
• UDI-Device Identifier: 10886704077442
• UDI-Public: 10886704077442
• 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
• Report Date (Section B): 09/27/2022

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: 01/31/2025
• Device Model Number: GLY123509
• Device Catalogue Number: GLY123509
• Device Lot Number: 30710693
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXSELSIOR SL10 MICROCATHETER; UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown