MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910015
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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 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.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 galaxy g3 mini coil 1mm x 1.5cm (glm910015, 30412522) was being used as the fourth coil.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 report of patient injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.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).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, a galaxy g3 mini coil 1mm x 1.5cm (glm910015, 30412522) was being used as the fourth coil.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 report of patient injury.A non-sterile galaxy g3 mini 1mm x 1.5cm was received inside of a pouch.Device was inspected and it was found to be in good and normal conditions.No kinks or other physical damages were observed.A lab sample microcatheter was flushed and the galaxy g3 mini 1mm x 3cm was advanced through it.No resistance was felt during the advancement.Microscopic inspection was performed.The embolic coil was found to be in good and normal conditions.The device was returned to cerenovus for further evaluation.Upon arrival, unit was found to be in good and normal conditions.No physical damages were noted.By physically measuring the coil and the marker band positions it has been determined that the actual length of the coil is 4cm-4.5cm and not the 1.5cm of the product reported.However, it could not be clarified if the device returned has relationship with the customer complaint.Embolic coil was advanced through a flushed lab sample microcatheter and no resistance was felt during the test.Under microscopic magnification, the embolic coil was found to be in good and normal conditions.The customer complaint could not be confirmed since the device performed without any problem.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precautions: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Multiple attempts to obtain additional information and clarification on the device received were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.

• Brand Name: GALAXY G3 MINI 1MM X 1.5CM
• 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: 13636356
• Report Number: 3008114965-2022-00159
• Device Sequence Number: 2214750
• Product Code: KRD
• UDI-Device Identifier: 10886704080206
• UDI-Public: 10886704080206
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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: 06/30/2023
• Device Model Number: GLM910015
• Device Catalogue Number: GLM910015
• Device Lot Number: 30412522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022; 05/06/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/28/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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