MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120308
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization targeting a vertebral artery dissecting aneurysm (vada), the complaint coil, a 3mm x 8cm galaxy g3 (gly120308 / lot# unknown) was used but it became unraveled.Continuous flush was maintained.On 18-oct-2022, the cerenovus sales representative provided the following additional information: ¿probably the introducer of the complaint coil was unable to advance at the hub part of the phenom¿ microcatheter (medtronic) and the complaint coil seemed to be stuck.¿ the physician kept attempting to advance the coil, but advancement was not possible.The complaint coil was removed and the physician noticed that it had become unraveled.There was no negative impact to the patient.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a coil embolization targeting a vertebral artery dissecting aneurysm (vada), the complaint coil, a 3mm x 8cm galaxy g3 (gly120308 / lot# unknown) was used but it became unraveled.Continuous flush was maintained.On 18-oct-2022, the cerenovus sales representative provided the following additional information: ¿probably the introducer of the complaint coil was unable to advance at the hub part of the phenom¿ microcatheter (medtronic) and the complaint coil seemed to be stuck.¿ the physician kept attempting to advance the coil, but advancement was not possible.The complaint coil was removed and the physician noticed that it had become unraveled.There was no negative impact to the patient.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.The lot number of the device is not known, therefore manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.It is possible that force may have inadvertently been applied during the attempts to advance the coil resulting in the coil becoming unraveled.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 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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 16-nov-2022.[additional information]: on 16-nov-2022, additional information was received.The information indicated that the lot number of the complaint device is 30737323.The complaint device had not reached the target aneurysm, the reported issue that the complaint coil unraveled occurred during the coil introduction into the concomitant phenom microcatheter.The information indicated that the complaint coil was withdrawn, but it had not been repositioned.There was resistance between the guidewire and the microcatheter during the first approach to the target site.There were no kinks in the microcatheter that could have contributed to the reported issue.The microcatheter was not repositioned over the coil while the coil was deployed out of the distal end of the microcatheter; the coil was not used like a guidewire to reposition the microcatheter.There was no blood flow restriction / reduction as a result of the reported issue.A review of manufacturing documentation associated with this lot (30737323) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.E.1: initial reporter phone: (b)(6).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 3MM X 8CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 15704302
• Report Number: 3008114965-2022-00670
• Device Sequence Number: 4973178
• Product Code: KRD
• UDI-Device Identifier: 10886704077466
• UDI-Public: 10886704077466
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 12/31/2024
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: 30737323
• 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: 10/16/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: PHENOM¿ MICROCATHETER (MEDTRONIC)
• Patient Sex: Unknown