MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910040
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the posterior inferior cerebellar artery (pica), two 1mm x 4cm galaxy g3 coils (glm910040, l15423) would not advance into a styker sl-10 45 tip 0165 microcatheter (mc).The following coils were used successfully with the same mc prior to or after the encountered resistance: spectra g3 and galaxy g3 mini (2.5x5,2x6,2x4,2x4, 1.5x4,1.5x4,1.5x3).It was not necessary to remove the mc.There was no damage to the complaint coils.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.Based on the product analysis of the galaxy g3 mini devices received, the embolic coil was kinked on one device and the embolic coil was stretched on the other one.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was kinked with non-concentric loops, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers is 3008114965-2022-00221.Complaint conclusion: as reported by the field, during a coil embolization to the posterior inferior cerebellar artery (pica), two 1mm x 4cm galaxy g3 coils (glm910040, l15423) would not advance into a styker sl-10 45 tip 0165 microcatheter (mc).The following coils were used successfully with the same mc prior to or after the encountered resistance: spectra g3 and galaxy g3 mini (2.5x5,2x6,2x4,2x4, 1.5x4,1.5x4,1.5x3).It was not necessary to remove the mc.There was no damage to the complaint coils.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.A non-sterile galaxy g3 mini 1mm x 4cm the core wire and introducer were observed in good conditions.Under microscopic inspection, the embolic coil was noted to be damage inside the introducer.A manufacturing record evaluation was performed for the finished device l15423 number, and no non-conformances related to the reported complaint condition were identified.The device was returned to cerenovus for further evaluation.Upon arrival, the core wire and introducer were found in good condition.Further examination under microscopic magnification revealed that the embolic coil was returned inside the introducer, and it was found to be kinked and with non-concentric loops.The impeded condition experienced during the procedure could not be tested due to the damages encountered on the embolic coil.These damages could be secondary to the reported issue and may have been caused inadvertently when trying to advance the embolic coil through the introducer.No other possible contributing factors could be detected, however, the customer complaint regarding the coil being impeded in the microcatheter can be confirmed based on this finding.Coil kinking 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 issue from occurring.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following precautions: if unusual friction is noticed during advancement or retraction of the micro coil 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, 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 micro coil as it is advanced into the infusion microcatheter.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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 4CM
• 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: 13870304
• Report Number: 3008114965-2022-00220
• Device Sequence Number: 17309790
• Product Code: KRD
• UDI-Device Identifier: 10886704080251
• UDI-Public: 10886704080251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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: 03/31/2022
• Device Model Number: GLM910040
• Device Catalogue Number: GLM910040
• Device Lot Number: L15423
• 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: 03/17/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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: GALAXY G3 MINI 1MM X 4CM; STYKER SL-10 45 TIP 0165 MICROCATHETER
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: White