MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910020
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Procode: krd/hcg.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.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, a 1mm x 2cm galaxy g3 coil (glm910020, 30633448) was used as the second coil.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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, d9, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a coil embolization, a 1mm x 2cm galaxy g3 coil (glm910020, 30633448) was used as the second coil.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.A non-sterile galaxy g3 4mm x 8cm was received contained in the decontamination pouch; however, it does not correspond to the involved device.No further information was able to be obtained.A manufacturing record evaluation was performed for the finished device 30633448 number, and no non-conformances related to the malfunction were identified.Impeded in microcatheter and coil unraveled/stretched in patient are known potential product failures associated with the use of the device.Per the galaxy g3 instructions for use (ifu): if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the events.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.Coil stretching is an indicative of the application of excessive force, possibly in an attempt to overcome the reported resistance.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 MINI 1MM X 2CM
• 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: 15587529
• Report Number: 3008114965-2022-00655
• Device Sequence Number: 12550028
• Product Code: KRD
• UDI-Device Identifier: 10886704080237
• UDI-Public: 10886704080237
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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: 07/31/2024
• Device Model Number: GLM910020
• Device Catalogue Number: GLM910020
• Device Lot Number: 30633448
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 12/06/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown